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We are seeking a highly skilled Senior R&D Engineer to join our team at Mentor Worldwide LLC, a member of the J&J Family of Companies. As a Senior R&D Engineer, you will be responsible for leading and contributing to various cross-functional project teams, including R&D, manufacturing, marketing, and regulatory.
Key Responsibilities- Lead the conceptualization, design, and development of new devices or elements of new devices with the intent of commercialization per Quality System Requirements.
- Contribute to the design and development of product line extensions and product improvements.
- Help lead the design, development, execution, and analysis of results of system, device, component, and material tests per laboratory best practices.
- Accurately and efficiently translate user and patient needs through design requirements, design specifications, and into verified and validated devices and procedures.
- Lead verification and validation activities through regulatory clearance and design transfer.
- Contribute strongly in the generation of intellectual property.
- Collaborate with external and internal customers to identify user needs and validate device and procedure designs.
- Collaborate with clinical, regulatory, quality, manufacturing, etc., to ensure the development of innovative and reliable devices that fulfill clinical needs within regulatory requirements.
- Help manage development partners and other external vendors to meet project requirements and timelines.
- Coordinate and execute technical and peer reviews; may also include coordination and execution of design reviews.
- May involve direct or indirect supervision of engineers and/or technicians.
- A minimum of a Bachelor's degree in mechanical or biomedical engineering or a related field, preferably mechanical engineering.
- At least 4 years of medical device industry experience.
- Familiar with design control requirements.
- Good written and verbal communication skills.
- Preferred qualifications include 5-10 years of experience in design, development, and commercialization of Class I-III medical devices, specifically electro-mechanical, disposable, minimally invasive, handheld surgical devices.
- Project Management Experience.
- Experience in working with cross-functional teams.
- Familiar with GMP & GLP.
- Designing with 3D CAD tools, including SolidWorks and rapid prototyping, including hands-on manual prototyping, SLA, and FDM.
- Experience in test method validation.
- Experience in executing design verification and validation.
Location: Irving, TX / Raritan, NJ
Travel: Less than 10% travel required
Office and lab environment
Ability to move materials and light equipment (up to 10 pounds) as needed
About Johnson & JohnsonAt Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
