Staff NPI Process Engineer
Johnson & Johnson MedTech is seeking a highly qualified and motivated individual to join our team as Sr. NPI Engineer based in Irvine, CA supporting Cardiovascular business units with focus on Structural Heart and Left Atrial Appendage LAA devices. We’re committed to delivering innovative products, solutions, and programs to address unmet customer and patient needs worldwide.
The Sr. NPI Engineer will work closely with the cross functional team to bring new products from development through commercialization and life cycle management.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Key Responsibilities:
- Design For Manufacture/Assembly: Partner closely with Design Engineering teams to develop and optimize manufacturing processes for new designs. Drive design for manufacturing, automation, and commercialization (DFx) activities on new concepts and products.
- New Process Development: Support rapid process revision and development, addressing process design risks in both function and manufacturability through test to deliver scalable design packages to production. Conceive and develop tradeoff studies that explore, test, and validate new manufacturing processes.
- New Design Realization: Lead the implementation of new designs into manufacturing processes, translating design intent into scalable production solutions. Define and own all Failure Mode Effects and Analysis (FMEA), Measurement Systems Analysis (MSA/Gauge R&R), and Process Capabilities Study (CPK) activities required to deliver and validate production of new designs.
- Test integration: Refine new product qualification and acceptance test processes, pulling in external resources such as test, manufacturing, tooling, vendors, integration, and other design groups as required to deliver stable and scalable testing methods.
- Technology Transfer: establish plans and manage transfer of technology from pilot plant to production site
- Validation and Qualification: Establish and manage validation master plan (IQ, OQ, PQ) and execute in partnership with cross functional teams through commercialization
- Cross-Functional Collaboration: Collaborate closely with R&D, Procurement, and production teams, owning the handoff from development to production.
