Johnson & Johnson's MedTech organization is seeking a NPI Manufacturing Engineering Manager to lead the New Product Introduction (NPI) team for the MONARCH business unit. This role is crucial for ensuring timely product launches and supporting the Instruments & Accessories (I&A) for the Monarch business unit, ultimately contributing to solving pressing healthcare challenges through surgical innovations.
Requirements
- Medical device experience with Class II or equivalent experience in capital & I&A development is required.
- Advanced skill level in process validation and test method validation preferred.
- Track record of influencing both strategic and tactical product decisions with insights derived from characterization studies is required.
- Experience improving manufacturing processes with process data and engineering studies is required.
- Knowledge of good manufacturing practices and documentation for production processes is required.
- Statistical Process Control (SPC) knowledge and management of statistical procedures is required.
- Excellent knowledge in Quality system, QSIT and FDA guidelines, 21CFR 820, 21 CFR Parts 210 and 211, ISO 13485, ISO 14971 and relevant guidance preferred.
Responsibilities
- Provides day-to-day tactical engineering direction and guidance for engineering associates supporting manufacturing to ensure short and long-term goals are met.
- Owns the successful implementation of new technology, processes and systems as well as continuous improvement to existing processes & technology.
- Identifies, designs, and develops equipment related to new product development.
- Responsible for preparing and delivering process and test specifications.
- Responsible for purchasing and designing equipment that meets J&J standards of safety and environment requirements.
- Responsible for developing new manufacturing and assembly processes consistent with Design for Manufacturability and Assembly for new product introductions in accordance with regulatory, industry, and J&J standards.
- Coordinates and performs qualification of new and improved manufacturing equipment and automation systems.
Other
- Demonstrate Credo based leadership.
- Grow the NPI (New Product Introduction) team's capabilities both by developing existing talent and hiring new talent as we continue to grow.
- Build strong teams through trust and mentorship.
- Accountable to the Johnson and Johnson Standards of Leadership (Credo Values, customer/Marketplace Focus, Innovation, Interpersonal and People Development).
- Ability and willingness to be based in San Jose CA and travel 10-20% domestic and international.
