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Senior NPD Process Development Engineer

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Johnson & Johnson

2d ago

  • Job
    Full-time
    Mid & Senior Level
  • Engineering
    Product
  • Galway

AI generated summary

  • You need a degree in Mechanical/Biomedical Engineering and 3-5 years in device development. Skills in process design, validation, project management, and problem-solving with strong communication are essential.
  • You will develop product designs, evaluate components, manage prototypes, drive process improvements, collaborate with suppliers, ensure quality controls, and mitigate project risks.

Requirements

  • Required Experience & Education
  • Degree in Mechanical or Biomedical Engineering or equivalent.
  • At least 3-5 years of medical device medical process/device design and development experience in a regulated environment.
  • Desirable Experience
  • Prior experience in medical device catheter process design and or manufacturing is highly desirable.
  • Understanding of product lifecycle and validation requirements for new product introduction.
  • Experienced in developing validation strategies for equipment or processes, including preparation of FMEA’s protocols and reports.
  • Proficiency in structured problem-solving approaches (e.g. Six Sigma, DMAIC)
  • Project Management experience, developing project schedules and managing resources and execution.
  • Experience in managing technical relationships with external suppliers and OEM is preferred.
  • Design tools and practices expertise including Design for Manufacture, Lean assembly, Solidworks, Prototyping and Test method development.
  • Strong understanding and proven experience using appropriate statistical tools throughout each project lifecycle stage.
  • Excellent communication / interpersonal skills required.
  • Ability to multi-task, working on multiple projects simultaneously.
  • High level of technical writing and reporting skills.
  • Strong work ethic, creative problem solving, capable of working on own initiative.

Responsibilities

  • Work collaboratively on cross-functional project teams to develop robust product design to ensure capable manufacturing processes (Design for Manufacture).
  • Evaluate critical to quality requirements for components used to build complex acute ischemic stroke devices and translate these requirements into component specifications that ensure components are manufacturable and performance is maintained consistently.
  • Assess new and existing raw materials, component, and assembly suppliers for technical and manufacturing capabilities.
  • Drive process/product improvements (design for manufacture/design for assembly) related to sub-assembly or component usage or design.
  • Manage prototype builds to support characterization and develop assessment strategies.
  • Develop strategies to characterize and validate new and improved manufacturing processes and components on external supplier manufacturing line and pilot lines.
  • Collaborate with suppliers and incoming inspection laboratories to develop, validate, and ensure appropriate inspection methods and controls are in place for components and finished devices.
  • Identify project risks and develop mitigation strategies to ensure supply, quality and timelines are met.
  • Monitor supplier performance and provide technical support to resolve issues.
  • Implement changes under the Cerenovus change management system.
  • Other duties as assigned or required.

FAQs

What is the job title for this position?

The job title is Senior NPI Process Development Engineer.

Where is this position located?

This position is located in Ballybrit, Galway, Ireland.

Who does this position report to?

This position reports to the NPI Process Development Engineering Manager (Supply Chain TLCME).

What is the primary responsibility of the Senior NPI Process Development Engineer?

The primary responsibility is to work with the product development team and suppliers to develop and deliver complex acute ischemic stroke projects from initial concept through to commercialization.

What qualifications are required for this position?

A degree in Mechanical or Biomedical Engineering or equivalent, along with at least 3-5 years of medical device design and development experience in a regulated environment is required.

Is experience in medical device catheter process design and manufacturing preferred?

Yes, prior experience in medical device catheter process design and/or manufacturing is highly desirable.

What kind of work environment does CERENOVUS provide?

CERENOVUS offers a positive work environment that respects diversity, supports well-being, and embraces innovation.

Does this job involve project management responsibilities?

Yes, project management experience, including developing project schedules and managing resources, is desirable for this position.

What type of culture does Johnson & Johnson promote?

Johnson & Johnson promotes a culture that values diversity, equity, and inclusion, aiming to create an environment where everyone feels they belong and can reach their potential.

Are there opportunities for personal and professional development in this role?

Yes, there are possibilities for further personal and professional development/education in this role.

Johnson & Johnson

Hospitals and Health Care

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Profound Change Requires Boldness. Johnson & Johnson is the largest and most diversified healthcare products company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world.