Senior R&D Engineer

2 days ago

Irving, Texas, United States Johnson and Johnson Full time
Job Title: Senior Engineer, R&D

Mentor Worldwide LLC, a member of Johnson & Johnson's Family of Companies, is seeking a highly skilled Senior Engineer, R&D to join our team.

Job Summary:

The Senior Engineer, R&D will lead and contribute to various cross-functional multidisciplinary project teams, including R&D, manufacturing, marketing, and regulatory. The successful candidate will design, develop, and manufacture Mentor products, including Breast Implants, Tissue Expanders, and other related products.

Key Responsibilities:
  • Lead conceptualization, design, and development of new devices or elements of new devices with the intent of commercialization per Quality System Requirements
  • Contribute to design/development of product line extensions and product improvements
  • Help lead 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/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 (e.g., clinicians) and internal customers (e.g., strategic marketing) to identify user needs and validate device and procedure designs
  • Collaborate with clinical, regulatory, quality, manufacturing, etc., to ensure 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
Qualifications:
  • A minimum of a Bachelor's degree in mechanical or biomedical engineering or related field, preferably mechanical engineering
  • At least 4 years medical device industry experience
  • Familiar with design control requirements
  • Good written and verbal communication skills
Preferred Qualifications:
  • 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 & Travel Requirements:

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

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.

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