Research and Development Medical Device Engineer

Energy Jobline

Aug 1

Applications are closed

Job
Full-time
Mid & Senior Level
Brooklyn

Requirements

BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific discipline with 4+ years of product development experience is required. An advanced degree (MS or Ph.D.) is highly preferred.
A minimum of 2 years of hands-on experience in new product research and development in a cGMP-regulated industry is required (work experience in the Medical Device field is strongly preferred).
Adept experimentalist with hands-on experience in product development of polymeric medical devices and their safety/efficacy characterization in an R&D environment is strongly preferred.
Experience gathering user needs, translating them to technical inputs, and developing viable V&V (Design Verification and Validation) plans required.
Experience leading complex product development initiatives from concept through release.
Experience developing test methods and protocols/reports for safety and efficacy testing of implant and instrument designs is strongly preferred.
Good working knowledge of anatomy and surgical procedures is desired.
Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements is required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively.
Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies is required. Six-Sigma green belt or black belt certification preferred.
Good understanding of statistical tools and validation/verification techniques is desired.
Demonstrated ability to work independently as well as effectively be a strong team contributor and work cross-functionally to expedite completion of critical project tasks is required.
Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner is required.
Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills is required.
Working knowledge of FDA requirements as per 21 CFR 820 and ISO 9001, ISO 13485:2003, and ISO 14971:2007 is strongly preferred.
Working knowledge of Good Documentation Practices (GDP), and Good Manufacturing Practices (cGMP) is preferred.
Requires strong leadership skills, and excellent written and verbal communication and presentation skills.
Proficient in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required.
Legal authorization to work in the United States is required.

Responsibilities

Create and lead experimentation for exploratory and/or product development research with a focus on polymeric materials devices and their use.
Define new product functional requirements (design inputs/user needs) and evaluate the design's overall effectiveness, cost, reliability, and safety.
Lead cross-functional teams to develop new products, address design issues, and maintain existing designs.
Apply strong problem-solving skills to find solutions to complex problems.
Work independently to plan and schedule own activities necessary to meet project timelines.
Work cooperatively with, quality, manufacturing, regulatory, clinical, and marketing to ensure project success.
Lead the creation of design history file documentation through the new product development process.
Develop new implant and instrument designs utilizing Solidworks and modeling/detail design specifications.
Generate technical protocols/reports to support device safety and efficacy.
Invent/create concepts and designs and submit invention disclosures.
Ensuring that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control and risk management requirements. Lead material/design/process changes through a design control process, with well-documented research/analyses.
Author protocols and reports including development studies and design verification/validation activities.
Develop and execute of test methods to aid in exploratory research, product development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes.
Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures.
Prepare samples as required for testing, or other evaluations and data analysis, including in voice-of-customer (VOC) labs.
Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication.
Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines.
Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions.
Provide support to marketing and sales team, support the introduction of new technologies with the development of presentations, sales tools, formulations, and applications data.
Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company.
Manage part-time staff as a research leader and mentor for ongoing research projects.
Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization.
Provide other project or product support as needed in order to support Cresilon’s business objective.
Responsibilities may include other duties as assigned and as required.

FAQs

What is the job title for this position?

The job title is Research and Development Medical Device Engineer.

Where is the office located?

The position is located in Brooklyn, New York.

What is the salary range for this position?

The competitive annual base salary range is $60,000 to $160,000, depending upon job level and qualifications.

What qualifications are required for this position?

A BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or a related scientific discipline with 4+ years of product development experience is required. An advanced degree (MS or Ph.D.) is highly preferred.

Is experience in the medical device field required?

Yes, a minimum of 2 years of hands-on experience in new product research and development in a cGMP-regulated industry, preferably in the Medical Device field, is required.

What kind of skills are essential for this role?

Strong problem-solving skills, the ability to analyze data using appropriate statistical methodologies, and good communication skills are essential.

Will I be working on cross-functional teams?

Yes, the Medical Device Engineer will work with a multidisciplinary team of researchers and collaborate with quality, manufacturing, regulatory, clinical, and marketing functions.

Are there any specific software or tools that I should be proficient in?

Proficiency in Solidworks for design, as well as Microsoft Excel, Word, and PowerPoint, is required.

What types of benefits does Cresilon offer?

Cresilon offers paid vacation, sick leave, holidays, 401(k) plans with company match, medical, dental, vision insurance, and more.

Is there any opportunity for professional development or research presentation?

Yes, the Medical Device Engineer will have the opportunity to communicate results to the scientific community via published papers and present research at academic and industry symposia.

Does Cresilon have a commitment to diversity in hiring?

Yes, Cresilon is an equal opportunity employer committed to a diverse and inclusive workplace, prohibiting discrimination and harassment of any kind.

Energy Jobline

Human Resources

Industry

11-50

Employees

2011

Founded Year

Mission & Purpose

Energy Jobline is a global job board that specialises in the energy, engineering, and power industries. They connect professionals with career opportunities in sectors like oil and gas, renewables, nuclear, and power generation. Their ultimate mission is to support the global energy workforce by providing a platform for job seekers to find relevant roles and for employers to access top talent. The purpose of Energy Jobline is to facilitate career development and recruitment in the energy sector, contributing to the industry's growth and innovation.