Senior NPI Engineer

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.

Join Abbott's Heart Failure business and play a key role in bringing the next generation of the CentriMag™ Circulatory Support System from development into global manufacturing. 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. Our Zurich Heart Failure site is home to approximately 160 employees, offering the visibility, ownership, agility, and family-like culture often associated with a smaller organization. Here, you can see the direct impact of your work, build strong cross-functional relationships, and influence key decisions. At the same time, you will be part of Abbott's global organization, collaborating closely with teams in Pleasanton, California and around the world while benefiting from the resources, stability, technology leadership, and career opportunities of one of the world's leading healthcare companies.

• 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 collaborating with external suppliers and contract manufacturers.

• Strong communication and technical writing skills.

• Fluent English.