Senior NPI Engineer

Shape the Future of Mechanical Circulatory Support Join Abbott's Heart Failure business and play a key role in bringing the next generation of the Centri Mag™ Circulatory Support System from development into global manufacturing.

As a Senior NPI Engineer, you will lead the industrialization, validation, and manufacturing scale-up of complex electromechanical medical devices that directly support critically ill cardiac patients.

This is a highly visible role with the opportunity to influence product design, manufacturing strategy, supplier readiness, and production ramp-up from early development through commercial launch.

A unique aspect of this position is the close collaboration between our teams in Zurich, Switzerland and Pleasanton, California.

Working as part of a highly integrated global organization, you will partner with experts across R&D, Quality, Regulatory, Operations, and Supplier Engineering to bring innovative technologies to market.

If you enjoy solving complex technical challenges, working hands-on with manufacturing processes, and turning innovative concepts into scalable products that improve patients' lives, we'd love to hear from you.

• Lead manufacturing process development, design transfer, and manufacturing readiness activities from concept through commercial launch.
• Develop, characterize, optimize, and scale manufacturing processes for assembly, calibration, testing, inspection, and packaging.
• Partner with R&D to drive Design for Manufacturability (DFM) and Design for Assembly (DFA) improvements.
• Translate product requirements into manufacturing requirements, process specifications, equipment requirements, and control strategies.
• Support engineering builds, pilot builds, clinical builds, and production ramp-up activities.

• Own process validation activities (IQ/OQ/PQ) for internal manufacturing processes and supplier operations.
• Develop validation plans, protocols, reports, and statistical justifications.
• Lead process characterization activities to ensure robust and capable manufacturing processes.
• Develop and maintain PFMEAs, control plans, CTQs, IPCs, manufacturing specifications, and work instructions.
• Support equipment qualification and test method validation activities.

• Serve as the technical manufacturing lead for external suppliers and manufacturing partners.
• Evaluate supplier process flows, PFMEAs, control plans, validation strategies, and manufacturing readiness.
• Drive alignment between internal and supplier manufacturing processes to enable successful commercialization.
• Collaborate closely with cross-functional teams in Zurich and Pleasanton to resolve technical challenges and support project milestones.
• Support root cause investigations, yield improvement initiatives, CAPA activities, and ongoing process optimization.

• Bachelor's degree in Electrical Engineering, Mechatronics, Mechanical Engineering, Manufacturing Engineering or a related engineering discipline.
• 7+ years of experience in New Product Introduction (NPI), Manufacturing Engineering, Process Development, Industrialization, or Design Transfer within a regulated industry.
• Experience developing and validating manufacturing processes for complex electromechanical products.
• Strong knowledge of process validation methodologies (IQ/OQ/PQ), manufacturing readiness, and design transfer.
• Experience developing manufacturing specifications, process documentation, PFMEAs, control plans, CTQs, and IPCs.
• Hands-on experience supporting engineering builds, pilot production, and manufacturing floor activities.
• Experience…