Principal Device Technical Owner, MSAT – Synthetics

Requisition Number: R-073358 Locations: Titusville, NJ (United States), Beerse, Antwerp (Belgium), Latina (Italy), Schaffhausen (Switzerland). Position Summary The Principal Device Technical Owner will lead the lifecycle engineering and technical support of device constituents for combination products in Johnson & Johnson Innovative Medicine. Responsibilities include transitioning from development to manufacturing, overseeing validation activities, and providing technical support to site operations and quality leadership within the scope of applicable regulatory requirements. Key Responsibilities

Lead device assembly design transfer, including process and equipment qualification (IQ/OQ/PQ), validation, and commissioning activities. Develop manufacturing strategy, equipment user requirements, and process failure mode and effects analysis (pFMEA). Lead process design and characterization studies. Qualify additional capacity for sub‑assembly and assembly processes to support device production. Support assembly sites in resolving technical issues. Improve processes and quality systems for combination products and device constituents. Conduct root‑cause investigations and produce technical documents.

Qualifications Education

Minimum bachelor’s degree in engineering; advanced or focused degree in mechanical, biomedical, or materials engineering is preferred.

Experience and Skills (Required)

Minimum 8 years of relevant experience. Experience in design and development of medical devices, combination products, or packaging processes. Experience in equipment design, qualification, and validation. Strong communication skills and ability to collaborate with external suppliers, contract manufacturers, and global partners. Demonstrated compliance experience with FDA CFR parts 3, 4, 210, 211, and 820 or ISO 13485 (design control, change control, CAPA, and complaint handling).

Preferred

Knowledge of plastic injection molding or metal materials and processing technologies. Experience leading global project teams or certification in project management. Experience with cleaning validations. Strong analytical problem‑solving skills and knowledge in applied statistics and statistical process control. Six Sigma Black Belt certification. Experience with financial analysis and business case development.

Other

Requires up to 25 % domestic and international travel; ability to work across time zones. Work arrangement: hybrid or onsite.

Compensation Anticipated pay range (Titusville, NJ): €79,800 – €137,770. Italy location pay range: €56,000 – €94,945. Benefits In addition to base pay, benefits include an annual bonus, vacation days, parental leave (minimum 12 weeks), bereavement leave, caregiver leave, volunteer leave, well‑being reimbursement, financial, physical and mental health programs, service anniversary awards, and eligible insurance plans. Details vary by location. #J-18808-Ljbffr