Senior Technical Specialist - Process Validation

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. Experience supporting production ramp-up and sustaining engineering after product launch. Experience with yield improvement, root cause investigations, and continuous process optimization in a manufacturing environment. Experience working with suppliers on process development, qualification, and manufacturing scale-up. German language skills are a plus. Why Join Abbott? Make a direct impact on technologies that help save and improve patients' lives. Lead critical industrialization activities for a next-generation circulatory support platform. Collaborate within a truly global team spanning Zurich, Switzerland and Pleasanton, California. Influence both product design and manufacturing strategy early in the development process. Work with advanced electromechanical medical technology in a highly innovative environment. Grow your career within one of the world's leading healthcare companies. The Best of Both Worlds 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. Ready to Apply? We're looking for curious, driven engineers who thrive in dynamic environments and enjoy transforming innovative ideas into robust manufacturing solutions. Even if your experience does not align perfectly with every qualification, we encourage you to apply. Join Abbott and help bring life-saving technologies to patients around the world. The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Manufacturing DIVISION: HF Heart Failure LOCATION: Switzerland : Technoparkstrass 1 CH 8005 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable