Every Organ Wasted is a Life Not Saved.

TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, and clinical care.

With more than 25 years of commitment to excellence and innovation, TransMedics is at the forefront of advancing the field of organ transplantation. Our innovative Organ Care System (OCS™) technology is the only FDA-approved technology for lung, heart and liver transplant indications in the U.S., enabling the optimization and assessment of donor organs outside the human body and replacing a decades-old outdated standard of care: static cold storage (ice). Combined with our National OCS Program (NOP), a nationwide team of clinical experts, 24/7 logistics support, and the first-of-its-kind dedicated air & ground transport logistics network, we are enabling transplant centers to expand their search criteria for viable organ donors and grow overall transplant volumes in the U.S.  

Science & Healthcare

TransMedics, Inc.

Redefining what's possible in organ transplantation

Manufacturing & Electronics

You need a relevant engineering degree, 7+ years of experience (3+ in leadership), knowledge of medical device regulations, strong project management, and automation skills.

You will lead the engineering team, oversee medical device design and testing, manage projects, collaborate cross-functionally, and drive automation initiatives while ensuring regulatory compliance.

Andover

<div>
 <div>
  Job Description:
 </div>
 <div></div>
 <div>
   Job Summary:
 </div>
 <div></div>
 <div>
   TransMedics was founded to address the growing need for healthier organs for transplantation. We are focused on transforming the standard of care – increasing organ utilization, improving patient outcomes, and reducing transplant costs.
 </div>
 <div></div>
 <div>
   The Engineering Manager for Perfusion Systems plays a pivotal role in driving process improvements and efficiency in manufacturing operations. We are seeking an experienced and dynamic Engineering Manager to join our team and lead our engineering department. The Engineering Manager will oversee the engineering team, manage the process development, and ensure that all projects meet regulatory standards and company objectives. This individual will be responsible for mentoring engineers, collaborating with cross-functional teams, and implementing best practices in engineering management, with an emphasis on automation.
 </div>
 <div></div>
 <div>
   ESSENTIAL DUTIES AND RESPONSIBILITIES:
 </div>
 <ul>
  <li> Lead and manage the engineering team, providing guidance, mentorship, and support.</li>
  <li> Oversee the design, development, and testing of equipment for the manufacture of medical devices, ensuring compliance with regulatory standards (e.g., ISO 13485, FDA).</li>
  <li> Develop and implement engineering strategies and processes to improve efficiency and product quality, with a focus on automation and process optimization.</li>
  <li> Collaborate with cross-functional teams, including R&amp;D, Quality Assurance, Regulatory Affairs, and Manufacturing, to drive projects from concept to commercialization.</li>
  <li> Manage project timelines, budgets, and resources to ensure successful project completion.</li>
  <li> Conduct performance reviews, provide constructive feedback, and create development plans for engineering staff.</li>
  <li> Identify and mitigate risks associated with engineering projects and processes.</li>
  <li> Ensure documentation and technical reports are accurate and comply with regulatory requirements.</li>
  <li> Stay current with industry trends, technologies, and best practices to maintain competitive advantage.</li>
  <li> Drive initiatives in automation to streamline manufacturing processes and enhance productivity.</li>
 </ul>
 <div>
   Qualifications:
 </div>
 <ul>
  <li> Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, or related field). Master’s degree preferred.</li>
  <li> Minimum of 7 years of experience in engineering roles, with at least 3 years in a leadership or managerial position within the medical device industry.</li>
  <li> Strong knowledge of medical device development processes, regulations, and standards (ISO 13485, FDA).</li>
  <li> Proven track record of managing and delivering complex engineering projects on time and within budget.</li>
  <li> Significant experience in automation technologies and their application in manufacturing processes.</li>
  <li> Excellent leadership, communication, and interpersonal skills.</li>
  <li> Ability to work collaboratively in a fast-paced, cross-functional team environment.</li>
  <li> Strong problem-solving skills and the ability to make data-driven decisions.</li>
  <li> Proficient in engineering software and tools (e.g., CAD, FEA, MATLAB).</li>
  <li> Strong knowledge of medical device regulations (FDA, ISO 13485, etc.).</li>
  <li> Demonstrated leadership and team management skills.</li>
  <li> Effective communication and collaboration skills.</li>
  <li> Familiarity with lean manufacturing principles and continuous improvement methodologies.</li>
  <li> Commitment to maintaining the highest quality and safety standards.</li>
 </ul>
 <div></div>
 <div>
   TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.
 </div>
</div>


 
  Job Description:
 
 
 
   Job Summary:
 
 
 
   TransMedics was founded to address the growing need for healthier organs for transplantation. We are focused on transforming the standard of care – increasing organ utilization, improving patient outcomes, and reducing transplant costs.
 
 
 
   The Engineering Manager for Perfusion Systems plays a pivotal role in driving process improvements and efficiency in manufacturing operations. We are seeking an experienced and dynamic Engineering Manager to join our team and lead our engineering department. The Engineering Manager will oversee the engineering team, manage the process development, and ensure that all projects meet regulatory standards and company objectives. This individual will be responsible for mentoring engineers, collaborating with cross-functional teams, and implementing best practices in engineering management, with an emphasis on automation.
 
 
 
   ESSENTIAL DUTIES AND RESPONSIBILITIES:
 
 
   Lead and manage the engineering team, providing guidance, mentorship, and support.
   Oversee the design, development, and testing of equipment for the manufacture of medical devices, ensuring compliance with regulatory standards (e.g., ISO 13485, FDA).
   Develop and implement engineering strategies and processes to improve efficiency and product quality, with a focus on automation and process optimization.
   Collaborate with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing, to drive projects from concept to commercialization.
   Manage project timelines, budgets, and resources to ensure successful project completion.
   Conduct performance reviews, provide constructive feedback, and create development plans for engineering staff.
   Identify and mitigate risks associated with engineering projects and processes.
   Ensure documentation and technical reports are accurate and comply with regulatory requirements.
   Stay current with industry trends, technologies, and best practices to maintain competitive advantage.
   Drive initiatives in automation to streamline manufacturing processes and enhance productivity.
 
 
   Qualifications:
 
 
   Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, or related field). Master’s degree preferred.
   Minimum of 7 years of experience in engineering roles, with at least 3 years in a leadership or managerial position within the medical device industry.
   Strong knowledge of medical device development processes, regulations, and standards (ISO 13485, FDA).
   Proven track record of managing and delivering complex engineering projects on time and within budget.
   Significant experience in automation technologies and their application in manufacturing processes.
   Excellent leadership, communication, and interpersonal skills.
   Ability to work collaboratively in a fast-paced, cross-functional team environment.
   Strong problem-solving skills and the ability to make data-driven decisions.
   Proficient in engineering software and tools (e.g., CAD, FEA, MATLAB).
   Strong knowledge of medical device regulations (FDA, ISO 13485, etc.).
   Demonstrated leadership and team management skills.
   Effective communication and collaboration skills.
   Familiarity with lean manufacturing principles and continuous improvement methodologies.
   Commitment to maintaining the highest quality and safety standards.
 
 
 
   TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.
 


Engineering Manager - TransMedics, Inc.

TransMedics

Engineering Manager

You must have 5+ years in Manufacturing Quality/Engineering, FDA/ISO knowledge, experience with complex medical devices, problem-solving skills, and proficiency in statistical tools. BS in relevant field required.

You will ensure compliance in manufacturing, drive nonconformance processes, analyze production data, support inspections, resolve yield issues, and assist in internal audits.

<div>
 <div>
  Job Description:
 </div>
 <div></div>
 <div>
   TransMedics, Inc. is a medical technology company that is transforming solid organ transplantation for patients with end-stage heart, lung, and liver failure. The Organ Care System (OCS™), a first-in-class proprietary device/solution platform, was developed to improve quality, validate viability, and increase the utilization of donor organs for transplantation. TransMedics OCS™ Heart, OCS™ Lung, and OCS™ Liver systems currently have both U.S. PMA approvals and are CE-Marked. TransMedics is the undisputed global leader in organ transplantation in a new multi-billion-dollar medical device industry.
 </div>
 <div></div>
 <div>
  <br> TransMedics is a rapidly growing organization dedicated to attracting and hiring top talent to deliver on our Mission to be the trusted partner to transplant stakeholders worldwide, focused on delivering the highest quality technology, services and clinical care to save patients’ lives.
 </div>
 <div></div>
 <div>
  <br> ESSENTIAL FUNCTIONS INCLUDE BUT ARE NOT LIMITED TO:
 </div>
 <ul>
  <li> Provide quality engineering support in the manufacturing of medical devices &amp; hardware.</li>
  <li> Ensure compliance of manufacturing processes and areas to all applicable quality system regulations</li>
  <li> Lead Nonconformance (NCMR) process such as inspection methods, containment, correction, closure and CAPAs, and drive continuous improvement through analysis of trend data.</li>
  <li> Monitor and analyze production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities.</li>
  <li> Work with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed (GMP)</li>
  <li> Support the inspection &amp; testing of raw materials, components &amp; finished products to ensure compliance with specifications &amp; quality standards.</li>
  <li> Resolve incoming inspection yield issues by driving tighter vendor process capabilities, ensuring appropriate internal drawing specifications, and validation of inspection methods.</li>
  <li> Lead analysis of defective components found in Incoming Inspection and work with suppliers to resolve (SCARs)</li>
  <li> Support internal auditing requirements in manufacturing to ensure compliance with quality system requirements.</li>
 </ul>
 <div></div>
 <div>
  <br> BACKGROUND AND QUALIFICATIONS:
 </div>
 <div>
  <ul>
   <li> Minimum of 5 years’ experience in a Manufacturing Quality and/or Manufacturing Engineering role</li>
  </ul>
 </div>
 <ul>
  <li> Working knowledge of Medical Device Regulations: FDA 21 CFR 820, ISO 14971 &amp; 13485 as well other applicable regulations and industry standards pertaining to Medical Devices.</li>
 </ul>
 <ul>
  <li> Experience with manufacturing of complex products in an Environmentally controlled area. Experience with medical capital equipment and electromechanical devices preferred.</li>
  <li> Experience with formal problem-solving methodologies and deductive skills, root cause analysis &amp; CAPA.</li>
  <li> Experience with handling non-conforming material and assemblies.</li>
  <li> Practical knowledge and experience using Minitab or other statistical analysis tools. Understanding &amp; application of Gage R&amp;R and Measurement system analysis desired.</li>
  <li> Utilization of statistical data analysis for trending purposes; ideally Six Sigma methods and tools</li>
  <li> Ability to communicate ideas and information clearly, effectively, and concisely.</li>
 </ul>
 <div></div>
 <div>
   EDUCATION:
 </div>
 <ul>
  <li> BS in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline.</li>
 </ul>
 <div></div>
 <div>
  <i><br> Notice of Recruitment Fraud</i>
 </div>
 <div>
  <i> It has come to our attention that individuals who are unaffiliated with TransMedics are posing as representatives and engaging with candidates regarding fake job opportunities. These fraudsters may request payment and/or financial information from you. These opportunities are not authorized by TransMedics. Please note that our recruiting process does not include asking candidates for payments of any kind and/or financial information under any circumstances.</i>
 </div>
 <div></div>
 <div>
  <i><br> For individuals in the United States, the following link may be useful in protecting yourself:</i><i> </i>
  <div>
   <i>https://consumer.ftc.gov/articles/job-scams</i>
  </div><i>. Please note that TransMedics is not responsible for the content of this website. For individuals outside of the United States, please check with your local authorities.</i>
 </div>
 <div></div>
 <div>
  <br> TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.
 </div>
</div>


 
  Job Description:
 
 
 
   TransMedics, Inc. is a medical technology company that is transforming solid organ transplantation for patients with end-stage heart, lung, and liver failure. The Organ Care System (OCS™), a first-in-class proprietary device/solution platform, was developed to improve quality, validate viability, and increase the utilization of donor organs for transplantation. TransMedics OCS™ Heart, OCS™ Lung, and OCS™ Liver systems currently have both U.S. PMA approvals and are CE-Marked. TransMedics is the undisputed global leader in organ transplantation in a new multi-billion-dollar medical device industry.
 
 
 
   TransMedics is a rapidly growing organization dedicated to attracting and hiring top talent to deliver on our Mission to be the trusted partner to transplant stakeholders worldwide, focused on delivering the highest quality technology, services and clinical care to save patients’ lives.
 
 
 
   ESSENTIAL FUNCTIONS INCLUDE BUT ARE NOT LIMITED TO:
 
 
   Provide quality engineering support in the manufacturing of medical devices & hardware.
   Ensure compliance of manufacturing processes and areas to all applicable quality system regulations
   Lead Nonconformance (NCMR) process such as inspection methods, containment, correction, closure and CAPAs, and drive continuous improvement through analysis of trend data.
   Monitor and analyze production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities.
   Work with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed (GMP)
   Support the inspection & testing of raw materials, components & finished products to ensure compliance with specifications & quality standards.
   Resolve incoming inspection yield issues by driving tighter vendor process capabilities, ensuring appropriate internal drawing specifications, and validation of inspection methods.
   Lead analysis of defective components found in Incoming Inspection and work with suppliers to resolve (SCARs)
   Support internal auditing requirements in manufacturing to ensure compliance with quality system requirements.
 
 
 
   BACKGROUND AND QUALIFICATIONS:
 
 
  
    Minimum of 5 years’ experience in a Manufacturing Quality and/or Manufacturing Engineering role
  
 
 
   Working knowledge of Medical Device Regulations: FDA 21 CFR 820, ISO 14971 & 13485 as well other applicable regulations and industry standards pertaining to Medical Devices.
 
 
   Experience with manufacturing of complex products in an Environmentally controlled area. Experience with medical capital equipment and electromechanical devices preferred.
   Experience with formal problem-solving methodologies and deductive skills, root cause analysis & CAPA.
   Experience with handling non-conforming material and assemblies.
   Practical knowledge and experience using Minitab or other statistical analysis tools. Understanding & application of Gage R&R and Measurement system analysis desired.
   Utilization of statistical data analysis for trending purposes; ideally Six Sigma methods and tools
   Ability to communicate ideas and information clearly, effectively, and concisely.
 
 
 
   EDUCATION:
 
 
   BS in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline.
 
 
 
   Notice of Recruitment Fraud
 
 
   It has come to our attention that individuals who are unaffiliated with TransMedics are posing as representatives and engaging with candidates regarding fake job opportunities. These fraudsters may request payment and/or financial information from you. These opportunities are not authorized by TransMedics. Please note that our recruiting process does not include asking candidates for payments of any kind and/or financial information under any circumstances.
 
 
 
   For individuals in the United States, the following link may be useful in protecting yourself: 
  
   https://consumer.ftc.gov/articles/job-scams
  . Please note that TransMedics is not responsible for the content of this website. For individuals outside of the United States, please check with your local authorities.
 
 
 
   TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.
 


Manufacturing Quality Engineer - TransMedics, Inc.

Manufacturing Quality Engineer

You need 5+ years in FDA/ISO medical device manufacturing, NPI experience, automation skills, Solidworks proficiency, lean Six Sigma knowledge, and a BS in Mechanical Engineering.

You will contribute to NPI manufacturing, develop robust processes, generate work instructions, lead PFMEA, collaborate with teams, and ensure quality and efficiency in production activities.

<div>
 <div>
  Job Description:
 </div>
 <div></div>
 <div>
   Position: Engineer III - NPI Manufacturing
 </div>
 <div>
   Reports To: NPI Manufacturing Manager
 </div>
 <div></div>
 <div>
   ESSENTIAL DUTIES AND RESPONSIBILITIES:
 </div>
 <ul>
  <li>
   <div>
     Contribute to NPI manufacturing activities associated with the development of TransMedics perfusion set products and OCS products.
   </div></li>
  <li>
   <div>
     Apply in-depth knowledge and experience as technical contributor for NPI Manufacturing activities for new product development initiatives.
   </div></li>
  <li>
   <div>
     Coordinate, identify, and implement robust manufacturing processes to ensure production capacity, efficiency, and quality standards are being met.
   </div></li>
  <li>
   <div>
     Generate and validate work instructions and test procedures.
   </div></li>
  <li>
   <div>
     Specify, design, and install equipment, tooling and fixtures used in production.
   </div></li>
  <li>
   <div>
     Lead PFMEA activities in coordination with product development, quality, and manufacturing engineering teams.
   </div></li>
  <li>
   <div>
     Participate in DFM and DFA activities to define manufacturing processes for new product and product enhancement programs.
   </div></li>
  <li>
   <div>
     Develop manufacturing assembly and test methods to ensure Critical to Quality (CTQ) requirements are met.
   </div></li>
  <li>
   <div>
     Develop Critical to Assembly (CTA) requirements as required for manufacturing processes.
   </div></li>
 </ul>
 <ul>
  <li>
   <div>
     Identify Key Performance Indicators and process capability metrics using Measurement System Analysis (MSA), Gage Repeatability and Reproducibility (GR&amp;R), and Statistical Process Control (SPC) techniques.
   </div></li>
  <li>
   <div>
     Represent TransMedics in collaboration with external and internal product development design teams to ensure new processes are capable and transferred effectively to manufacturing.
   </div></li>
  <li>
   <div>
     Collaborate and communicate with cross-functional teams and leadership.
   </div></li>
  <li>
   <div>
     Perform other TransMedics tasks and duties as required.
   </div></li>
 </ul>
 <div>
   BACKGROUND AND QUALIFICATIONS:
 </div>
 <ul>
  <li>
   <div>
     5+ years of experience working in an FDA/ISO regulated medical device/medical equipment manufacturing environment.
   </div></li>
  <li>
   <div>
     Must have prior NPI Manufacturing and/or Process Development experience, including disposables and capital equipment.
   </div></li>
  <li>
   <div>
     Must have demonstrated experience in the selection and qualification of assembly equipment and automation.
   </div></li>
  <li>
   <div>
     Demonstrated expertise in automated assembly methods, robotics, PLCs, automated inspection, and fixture design.
   </div></li>
  <li>
   <div>
     Knowledgeable in injection molding and plastic joining techniques, including ultrasonic/RF/laser welding and adhesive/solvent bonding.
   </div></li>
  <li>
   <div>
     Proficient with Solidworks to create 3D models and drawings to support manufacturing assembly models, fixtures, and tooling.
   </div></li>
  <li>
   <div>
     Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus. Experience using Minitab or similar statistical evaluation software/tools preferred.
   </div></li>
  <li>
   <div>
     Effective analytical and decision-making skills.
   </div></li>
  <li>
   <div>
     Detail oriented with strong organizational skills.
   </div></li>
  <li>
   <div>
     Able to work collaboratively in a cross-functional team environment.
   </div></li>
  <li>
   <div>
     Excellent verbal and written communication skills.
   </div></li>
 </ul>
 <div></div>
 <ul>
  <li>EDUCATION: BS in Mechanical Engineering or other engineering discipline is required.</li>
 </ul>
 <div></div>
 <div>
   TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.
 </div>
</div>


 
  Job Description:
 
 
 
   Position: Engineer III - NPI Manufacturing
 
 
   Reports To: NPI Manufacturing Manager
 
 
 
   ESSENTIAL DUTIES AND RESPONSIBILITIES:
 
 
  
   
     Contribute to NPI manufacturing activities associated with the development of TransMedics perfusion set products and OCS products.
   
  
   
     Apply in-depth knowledge and experience as technical contributor for NPI Manufacturing activities for new product development initiatives.
   
  
   
     Coordinate, identify, and implement robust manufacturing processes to ensure production capacity, efficiency, and quality standards are being met.
   
  
   
     Generate and validate work instructions and test procedures.
   
  
   
     Specify, design, and install equipment, tooling and fixtures used in production.
   
  
   
     Lead PFMEA activities in coordination with product development, quality, and manufacturing engineering teams.
   
  
   
     Participate in DFM and DFA activities to define manufacturing processes for new product and product enhancement programs.
   
  
   
     Develop manufacturing assembly and test methods to ensure Critical to Quality (CTQ) requirements are met.
   
  
   
     Develop Critical to Assembly (CTA) requirements as required for manufacturing processes.
   
 
 
  
   
     Identify Key Performance Indicators and process capability metrics using Measurement System Analysis (MSA), Gage Repeatability and Reproducibility (GR&R), and Statistical Process Control (SPC) techniques.
   
  
   
     Represent TransMedics in collaboration with external and internal product development design teams to ensure new processes are capable and transferred effectively to manufacturing.
   
  
   
     Collaborate and communicate with cross-functional teams and leadership.
   
  
   
     Perform other TransMedics tasks and duties as required.
   
 
 
   BACKGROUND AND QUALIFICATIONS:
 
 
  
   
     5+ years of experience working in an FDA/ISO regulated medical device/medical equipment manufacturing environment.
   
  
   
     Must have prior NPI Manufacturing and/or Process Development experience, including disposables and capital equipment.
   
  
   
     Must have demonstrated experience in the selection and qualification of assembly equipment and automation.
   
  
   
     Demonstrated expertise in automated assembly methods, robotics, PLCs, automated inspection, and fixture design.
   
  
   
     Knowledgeable in injection molding and plastic joining techniques, including ultrasonic/RF/laser welding and adhesive/solvent bonding.
   
  
   
     Proficient with Solidworks to create 3D models and drawings to support manufacturing assembly models, fixtures, and tooling.
   
  
   
     Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus. Experience using Minitab or similar statistical evaluation software/tools preferred.
   
  
   
     Effective analytical and decision-making skills.
   
  
   
     Detail oriented with strong organizational skills.
   
  
   
     Able to work collaboratively in a cross-functional team environment.
   
  
   
     Excellent verbal and written communication skills.
   
 
 
 
  EDUCATION: BS in Mechanical Engineering or other engineering discipline is required.
 
 
 
   TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.
 


Engineer III - NPI Manufacturing - TransMedics, Inc.

Engineer III - NPI Manufacturing

You need 8+ years in FDA/ISO medical device manufacturing, NPI experience, expertise in assembly tech, Solidworks proficiency, and strong analytical skills. BS in Mechanical Engineering required.

You will lead NPI manufacturing activities, develop processes, create instructions, manage equipment needs, conduct PFMEA, ensure quality standards, and collaborate with teams for efficient product transfer.

<div>
 <div>
  Job Description:
 </div>
 <div></div>
 <div>
   Transmedics New Product Introduction (NPI) Manufacturing team is currently seeking talented candidates interested in bringing life changing new products to market. Reporting to the NPI Manufacturing Manager, within the Advanced Operations group, the Sr Manufacturing Engineer<i> </i>will have the opportunity to push the boundaries of manufacturing excellence for an exciting, fast-growing company that is transforming Organ Transplantation.
 </div>
 <div></div>
 <div>
   ESSENTIAL FUNCTIONS:
 </div>
 <ul>
  <li>
   <div>
     Contribute to NPI manufacturing activities associated with the development of TransMedics perfusion set products and OCS products.
   </div></li>
  <li>
   <div>
     Apply in-depth knowledge and experience as technical contributor for NPI Manufacturing activities for new product development initiatives.
   </div></li>
  <li>
   <div>
     Coordinate, identify, and implement robust manufacturing processes to ensure production capacity, efficiency, and quality standards are being met.
   </div></li>
  <li>
   <div>
     Generate manufacturing instructions and routers with sufficent detail and clarity.
   </div></li>
  <li>
   <div>
     Identify, specify, acquire, and install capital equipment, tooling, and fixtures for use in production.
   </div></li>
  <li>
   <div>
     Lead PFMEA activities in coordination with product development, quality, and manufacturing engineering teams.
   </div></li>
  <li>
   <div>
     Lead DFM and DFA activities to define manufacturing processes for new product and product enhancement programs.
   </div></li>
  <li>
   <div>
     Develop manufacturing assembly and test methods to ensure Critical to Quality (CTQ) requirements are met.
   </div></li>
  <li>
   <div>
     Identify KPIV and KPOV metrics for process development, to ensure robust manufacturing processes.
   </div></li>
  <li>
   <div>
     Contribute to Process Validations (IQ, OQ, PQ) for efficient line transfer to production.
   </div></li>
  <li>
   <div>
     Represent TransMedics in collaboration with external and internal NPI design teams to ensure new processes are capable and transferred effectively to manufacturing.
   </div></li>
  <li>
   <div>
     Collaborate and communicate with cross-functional teams and leadership.
   </div></li>
  <li>
   <div>
     Perform other TransMedics tasks and duties as required.
   </div></li>
 </ul>
 <div> 
 </div>
 <div>
   QUALIFICATIONS:
 </div>
 <div>
  <ul>
   <li>
    <div>
      8+ years of experience working in an FDA/ISO regulated medical device/medical equipment manufacturing environment.
    </div></li>
   <li>
    <div>
      Must have prior NPI Manufacturing and/or Process Development experience, including disposables and capital equipment.
    </div></li>
   <li>
    <div>
      Must have demonstrated experience in the selection and qualification of assembly equipment and automation.
    </div></li>
   <li>
    <div>
      Demonstrated expertise in a variety of manufacturing and assembly technologies and able to effectively implement said technologies with quality and cost in mind.
    </div></li>
   <li>
    <div>
      Knowledgeable in injection molding and plastic joining techniques, including ultrasonic/RF/laser welding and adhesive/solvent bonding.
    </div></li>
   <li>
    <div>
      Proficient with Solidworks to create 3D models and drawings to support manufacturing assembly models, fixtures, and tooling.
    </div></li>
   <li>
    <div>
      Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus. Experience using Minitab or similar statistical evaluation software/tools preferred.
    </div></li>
   <li>
    <div>
      Effective analytical and decision-making skills.
    </div></li>
   <li>
    <div>
      Detail oriented with strong organizational skills.
    </div></li>
   <li>
    <div>
      Able to work collaboratively in a cross-functional team environment.
    </div></li>
   <li>
    <div>
      Excellent verbal and written communication skills.
    </div></li>
  </ul>
 </div>
 <div> 
 </div>
 <div>
   EDUCATION:
 </div>
 <div>
  <ul>
   <li>
    <div>
      BS in Mechanical Engineering or other engineering discipline is required.
    </div></li>
  </ul>
 </div>
 <div></div>
 <div>
   TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.
 </div>
</div>


 
  Job Description:
 
 
 
   Transmedics New Product Introduction (NPI) Manufacturing team is currently seeking talented candidates interested in bringing life changing new products to market. Reporting to the NPI Manufacturing Manager, within the Advanced Operations group, the Sr Manufacturing Engineer will have the opportunity to push the boundaries of manufacturing excellence for an exciting, fast-growing company that is transforming Organ Transplantation.
 
 
 
   ESSENTIAL FUNCTIONS:
 
 
  
   
     Contribute to NPI manufacturing activities associated with the development of TransMedics perfusion set products and OCS products.
   
  
   
     Apply in-depth knowledge and experience as technical contributor for NPI Manufacturing activities for new product development initiatives.
   
  
   
     Coordinate, identify, and implement robust manufacturing processes to ensure production capacity, efficiency, and quality standards are being met.
   
  
   
     Generate manufacturing instructions and routers with sufficent detail and clarity.
   
  
   
     Identify, specify, acquire, and install capital equipment, tooling, and fixtures for use in production.
   
  
   
     Lead PFMEA activities in coordination with product development, quality, and manufacturing engineering teams.
   
  
   
     Lead DFM and DFA activities to define manufacturing processes for new product and product enhancement programs.
   
  
   
     Develop manufacturing assembly and test methods to ensure Critical to Quality (CTQ) requirements are met.
   
  
   
     Identify KPIV and KPOV metrics for process development, to ensure robust manufacturing processes.
   
  
   
     Contribute to Process Validations (IQ, OQ, PQ) for efficient line transfer to production.
   
  
   
     Represent TransMedics in collaboration with external and internal NPI design teams to ensure new processes are capable and transferred effectively to manufacturing.
   
  
   
     Collaborate and communicate with cross-functional teams and leadership.
   
  
   
     Perform other TransMedics tasks and duties as required.
   
 
  
 
 
   QUALIFICATIONS:
 
 
  
   
    
      8+ years of experience working in an FDA/ISO regulated medical device/medical equipment manufacturing environment.
    
   
    
      Must have prior NPI Manufacturing and/or Process Development experience, including disposables and capital equipment.
    
   
    
      Must have demonstrated experience in the selection and qualification of assembly equipment and automation.
    
   
    
      Demonstrated expertise in a variety of manufacturing and assembly technologies and able to effectively implement said technologies with quality and cost in mind.
    
   
    
      Knowledgeable in injection molding and plastic joining techniques, including ultrasonic/RF/laser welding and adhesive/solvent bonding.
    
   
    
      Proficient with Solidworks to create 3D models and drawings to support manufacturing assembly models, fixtures, and tooling.
    
   
    
      Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus. Experience using Minitab or similar statistical evaluation software/tools preferred.
    
   
    
      Effective analytical and decision-making skills.
    
   
    
      Detail oriented with strong organizational skills.
    
   
    
      Able to work collaboratively in a cross-functional team environment.
    
   
    
      Excellent verbal and written communication skills.
    
  
 
  
 
 
   EDUCATION:
 
 
  
   
    
      BS in Mechanical Engineering or other engineering discipline is required.
    
  
 
 
 
   TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.
 


Senior NPI Manufacturing Engineer - TransMedics, Inc.

Senior NPI Manufacturing Engineer

You must have a BS in Engineering, 8+ years in medical device development, knowledge of 21 CFR Part 820, ISO 13485, and statistical tools, plus experience in process validation and communication skills.

You will ensure design control processes meet customer and regulatory standards, review documentation, manage change notices, and provide expertise on quality engineering and risk management.

<div>
 <div>
  Job Description:
 </div>
 <div></div>
 <div>
   TransMedics, Inc., headquartered in Andover, MA, is revolutionizing organ care. With the goal of bringing new life to organ transplant, the pioneering Organ Care System (OCS™) was developed to address the major limitations of the current standard of care, cold storage. The OCS System serves as a portable, miniature intensive care unit that helps preserve donor organs in a near-physiologic state during transport. Unlike traditional cold-storage methods, the OCS System features ex-vivo, warm perfusion, and provides the means to monitor organ health, so that transplant patients can experience better outcomes. The only multi-organ platform, with the largest body of clinical evidence, the OCS System is designed to increase utilization and transplant volumes so that more transplantable organs can be made available worldwide. The Organ Care System is nothing less than a paradigm shift that can help transform organ preservation and optimization so that more patients can benefit from life-saving transplant procedures.
 </div>
 <div></div>
 <div>
   This position is responsible for various Design Quality Engineering functions in support of product development such as risk management, design verification, design validation, design assurance activities, as well as manufacturing process development support, and statistical analysis.
 </div>
 <div></div>
 <div>
   ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:
 </div>
 <ul>
  <li> Responsible for the overall health of design control process. Responsible for assuring NPI and sustaining projects meet customer expectations, and regulatory requirements.</li>
  <li> Partner with Development and Engineering departments and ensure that design control requirements are being met in an effective manner in order to achieve quality by design, including those for design verification, validation, specification and procedure development, risk management, and design review</li>
  <li> Provides input to design and manufacturing engineering project DHF deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Review DHF files for accuracy and completeness and provide guidance on FDA compliance and procedures.</li>
  <li> Review and approve design control related Change Notices (CNs) within the documentation system as applicable.</li>
  <li> Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards.</li>
  <li> Represent the design quality functions for the review and approval of designated design outputs.</li>
  <li> Act as a subject matter expert on design control process and Quality Engineering. The Quality Engineering subjects are Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, Process Validation (PV).</li>
  <li> Support the quality management system as required.</li>
  <li> Perform other TransMedics task and duties as required.</li>
 </ul>
 <div></div>
 <div>
  <br> REQUIREMENTS:
 </div>
 <ul>
  <li> BS in Engineering with 8+ years of related experience or equivalent combination of education and experience.</li>
  <li> Medical device development control experience required.</li>
  <li> Working knowledge of Software development lifecycle desired.</li>
  <li> Working knowledge and practical application of 21 CFR Part 820, ISO 13485, ISO 14971.</li>
  <li> Practical knowledge and experience using Minitab or other statistical analysis tools.</li>
  <li> Understanding and application of Gage R&amp;R and Measurement System Analysis desired</li>
  <li> Process validation experience including IQ/OQ/PQ desired.</li>
  <li> Ability to communicate ideas and information clearly, effectively and concisely.</li>
  <li> Highly detail oriented with strong organization and prioritization skills.</li>
 </ul>
 <div></div>
 <div>
   EDUCATION:
 </div>
 <ul>
  <li> BS in Engineering or other technical discipline</li>
 </ul>
 <div></div>
 <div>
   TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.
 </div>
</div>


 
  Job Description:
 
 
 
   TransMedics, Inc., headquartered in Andover, MA, is revolutionizing organ care. With the goal of bringing new life to organ transplant, the pioneering Organ Care System (OCS™) was developed to address the major limitations of the current standard of care, cold storage. The OCS System serves as a portable, miniature intensive care unit that helps preserve donor organs in a near-physiologic state during transport. Unlike traditional cold-storage methods, the OCS System features ex-vivo, warm perfusion, and provides the means to monitor organ health, so that transplant patients can experience better outcomes. The only multi-organ platform, with the largest body of clinical evidence, the OCS System is designed to increase utilization and transplant volumes so that more transplantable organs can be made available worldwide. The Organ Care System is nothing less than a paradigm shift that can help transform organ preservation and optimization so that more patients can benefit from life-saving transplant procedures.
 
 
 
   This position is responsible for various Design Quality Engineering functions in support of product development such as risk management, design verification, design validation, design assurance activities, as well as manufacturing process development support, and statistical analysis.
 
 
 
   ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:
 
 
   Responsible for the overall health of design control process. Responsible for assuring NPI and sustaining projects meet customer expectations, and regulatory requirements.
   Partner with Development and Engineering departments and ensure that design control requirements are being met in an effective manner in order to achieve quality by design, including those for design verification, validation, specification and procedure development, risk management, and design review
   Provides input to design and manufacturing engineering project DHF deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Review DHF files for accuracy and completeness and provide guidance on FDA compliance and procedures.
   Review and approve design control related Change Notices (CNs) within the documentation system as applicable.
   Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards.
   Represent the design quality functions for the review and approval of designated design outputs.
   Act as a subject matter expert on design control process and Quality Engineering. The Quality Engineering subjects are Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, Process Validation (PV).
   Support the quality management system as required.
   Perform other TransMedics task and duties as required.
 
 
 
   REQUIREMENTS:
 
 
   BS in Engineering with 8+ years of related experience or equivalent combination of education and experience.
   Medical device development control experience required.
   Working knowledge of Software development lifecycle desired.
   Working knowledge and practical application of 21 CFR Part 820, ISO 13485, ISO 14971.
   Practical knowledge and experience using Minitab or other statistical analysis tools.
   Understanding and application of Gage R&R and Measurement System Analysis desired
   Process validation experience including IQ/OQ/PQ desired.
   Ability to communicate ideas and information clearly, effectively and concisely.
   Highly detail oriented with strong organization and prioritization skills.
 
 
 
   EDUCATION:
 
 
   BS in Engineering or other technical discipline
 
 
 
   TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.
 


TransMedics, Inc.

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