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 Parts 3, 4, 11, 210, 211 and 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
Education
* Minimum of Bachelor’s in Engineering degree required; advanced degree or focused degree in Mechanical, Biomedical, or Materials Engineering is preferred
Required Experience and Skills
* 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 part 3, 4, 210, 211, 820, or ISO 13485 (e.g., Design Control, Change Control, CAPA, and Complaint Handling)
Preferred Experience and Skills
* 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
Benefits
In addition to base pay, we offer an annual bonus with set target (% of pay) depending on pay grade and location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. We also offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees – and in some locations’ eligible dependents – can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
Pay Range
The anticipated pay range for this position, in the primary posting location, is: €79,800.00 - €137,770.00
Italy – The expected base pay range for this position is 56,000 - 94,945 (EUR)
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