Principal Device Technical Owner, MSAT (Manufacturing Science and Technology) – Synthetics
Location: Titusville, NJ (Onsite/Hybrid); alternative locations: Beerse, Belgium; Latina, Italy; Schaffhausen, Switzerland.
Job Function: Supply Chain Engineering; Sub Function: Packaging Design Engineering; Category: Scientific/Technology; All Job Posting Locations: Schaffhausen, Switzerland.
Position Summary
The Principal Device Technical Owner will oversee the lifecycle engineering and technical support for device constituents of combination products in Johnson & Johnson Innovative Medicine. The role transitions responsibilities from development to manufacturing and provides technical support including change control assessments, process improvements, complaint investigations, CAPA, and audit support. This person will be the key point of contact for site operations and quality leadership within their area of responsibility.
The Owner will ensure all validation activities and ongoing production at suppliers, external manufacturers, and internal manufacturing and assembly sites comply with applicable procedures and the requirements of 21 CFR Parts 3, 4, 11, 210, 211, 820 and J&J Policy Standards related to GMP for Combination Products, Pharmaceuticals, and Medical Devices.
Key Responsibilities
* Lead device assembly design transfer, including process and equipment qualification (IQ/OQ/PQ), validation, and commissioning activities.
* Lead development of manufacturing strategy, equipment User Requirements and process Failure Mode and Effects Analysis (pFMEA).
* Lead process design and characterization studies.
* Develop and qualify additional capacity for sub‑assembly and assembly processes per manufacturing network strategies for the production of devices.
* Support assembly sites in solving technical issues.
* Lead or contribute to process and quality system improvements for combination products and device constituents.
* Perform root cause investigations and produce technical documents.
Qualifications
Education
* Minimum of a Bachelor’s degree in Engineering; advanced degree or focused degree in Mechanical, Biomedical, or Materials Engineering preferred.
Experience and Skills – Required
* Minimum 8 years of relevant work experience.
* Experience in design and development of Medical Devices, Combination Products, or packaging processes in the Medical Device, Biomedical, or Pharmaceutical industries.
* Experience in equipment design, qualification, and validation.
* Proven interpersonal 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, 820 or ISO 13485 (e.g., Design Control, Change Control, CAPA, and Complaint Handling).
Experience and Skills – Preferred
* Knowledge in 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, including ability to work in an international environment across different time zones.
Equal Employment Opportunity Statement
Johnson & Johnson is an equal opportunity employer and committed to building an inclusive, diverse workplace.
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