Principal Device Technical Owner, MSAT – Synthetics

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at are searching for the best talent for a Principal Device Technical Owner MSAT (Manufacturing Science and Technology) Synthetics ! This position is located (onsite/hybrid) in Titusville NJ. Alternate locations may be considered in Beerse Belgium; Latina Italy or Schaffhausen Switzerland.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

United States Puerto Rico- Requisition Number: R-072257

Belgium Italy - Requisition Number: R-073358

Switzerland - Requisition Number: R-073346

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

Position Summary:

Our Principal Device Technical Owner will be responsible for the ongoing lifecycle engineering and technical support of the device constituent for combination products in Johnson & Johnson Innovative Medicine. This engineer will transition the responsibilities from development to manufacturing and take accountability for technical support including change control assessments process improvements complaint investigations CAPA and audit support as required. This person will be the key point of contact to site operations and quality leadership for their area of responsibility.

The Principal Device Technical Owner will ensure all validation activities and ongoing production conducted at suppliers external manufacturers and internal manufacturing and assembly sites are in compliance with all applicable procedures and to the requirements of 21 CFR Partsand 820 and Johnson & Johnson Policy Standards related to Good Manufacturing Practice (cGMP) 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 the improvement of processes and quality systems in support of combination products and the device constituents of combination products

• Effectively perform root cause investigations and write technical documents

Qualifications:

Education:

• Minimum of Bachelors in Engineering degree required; advanced degree or focused degree in Mechanical Biomedical or Materials Engineering is 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 one or more of the following is required: FDA CFR partor ISO 13485 (e.g. Design Control Change Control CAPA and Complaint Handling)

Preferred:

• Knowledge in plastic injection molding or metal materials and processing technologies

• Experience in 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

Hybrid#