Senior NPI Engineer

JOB DESCRIPTION: Senior NPI Engineer – New Product Introduction 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 CentriMag ™ 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. What You'll Do New Product Introduction & Manufacturing Scale-Up 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. Process Validation & Technical Leadership 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. Supplier & Cross-Functional Collaboration 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. Required Qualifications 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. Preferred Qualifications Experience with medical devices or capital equipment incorporating electronics, motors, LCD displays, sensors, connectors, and user interface components. Proficiency with statistical methods and process characterization tools, including DOE, Gage R&R, MSA, capability studies (Cp/ Cpk ), and process validation techniques. Experience applying Lean Manufacturing and/or Six Sigma methodologies.