Senior NPI Engineer

h3JOB DESCRIPTION: /h3 pSenior NPI Engineer – New Product Introduction /p pShape the Future of Mechanical Circulatory Support /p pJoin bAbbott's Heart Failure /b business and play a key role in bringing the next generation of the CentriMag™ Circulatory Support System from development into global manufacturing. /p pAs a bSenior NPI Engineer /b, 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. /p pA 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 RD, Quality, Regulatory, Operations, and Supplier Engineering to bring innovative technologies to market. /p pIf 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. /p h3What You'll Do /h3 h3New Product Introduction Manufacturing Scale-Up /h3 ul lipLead manufacturing process development, design transfer, and manufacturing readiness activities from concept through commercial launch. /p /li lipDevelop, characterize, optimize, and scale manufacturing processes for assembly, calibration, testing, inspection, and packaging. /p /li lipPartner with RD to drive Design for Manufacturability (DFM) and Design for Assembly (DFA) improvements. /p /li lipTranslate product requirements into manufacturing requirements, process specifications, equipment requirements, and control strategies. /p /li lipSupport engineering builds, pilot builds, clinical builds, and production ramp-up activities. /p /li /ul h3Process Validation Technical Leadership /h3 ul lipOwn process validation activities (IQ/OQ/PQ) for internal manufacturing processes and supplier operations. /p /li lipDevelop validation plans, protocols, reports, and statistical justifications. /p /li lipLead process characterization activities to ensure robust and capable manufacturing processes. /p /li lipDevelop and maintain PFMEAs, control plans, CTQs, IPCs, manufacturing specifications, and work instructions. /p /li lipSupport equipment qualification and test method validation activities. /p /li /ul h3Supplier Cross-Functional Collaboration /h3 ul lipServe as the technical manufacturing lead for external suppliers and manufacturing partners. /p /li lipEvaluate supplier process flows, PFMEAs, control plans, validation strategies, and manufacturing readiness. /p /li lipDrive alignment between internal and supplier manufacturing processes to enable successful commercialization. /p /li lipCollaborate closely with cross-functional teams in Zurich and Pleasanton to resolve technical challenges and support project milestones. /p /li lipSupport root cause investigations, yield improvement initiatives, CAPA activities, and ongoing process optimization. /p /li /ul h3Required Qualifications /h3 ul lipBachelor's degree in Electrical Engineering, Mechatronics, Mechanical Engineering, Manufacturing Engineering or a related engineering discipline. /p /li lip7+ years of experience in New Product Introduction (NPI), Manufacturing Engineering, Process Development, Industrialization, or Design Transfer within a regulated industry. /p /li lipExperience developing and validating manufacturing processes for complex electromechanical products. /p /li lipStrong knowledge of process validation methodologies (IQ/OQ/PQ), manufacturing readiness, and design transfer. /p /li lipExperience developing manufacturing specifications, process documentation, PFMEAs, control plans, CTQs, and IPCs. /p /li lipHands-on experience supporting engineering builds, pilot production, and manufacturing floor activities. /p /li lipExperience collaborating with external suppliers and contract manufacturers. /p /li lipStrong communication and technical writing skills. /p /li lipFluent English. /p /li /ul h3Preferred Qualifications /h3 ul lipExperience with medical devices or capital equipment incorporating electronics, motors, LCD displays, sensors, connectors, and user interface components. /p /li lipProficiency with statistical methods and process characterization tools, including DOE, Gage RR, MSA, capability studies (Cp/Cpk), and process validation techniques. /p /li lipExperience applying Lean Manufacturing and/or Six Sigma methodologies. /p /li lipExperience supporting production ramp-up and sustaining engineering after product launch. /p /li lipExperience with yield improvement, root cause investigations, and continuous process optimization in a manufacturing environment. /p /li lipExperience working with suppliers on process development, qualification, and manufacturing scale-up. /p /li lipGerman language skills are a plus. /p /li /ul h3Why Join Abbott? /h3 ul lipMake a direct impact on technologies that help save and improve patients' lives. /p /li lipLead critical industrialization activities for a next-generation circulatory support platform. /p /li lipCollaborate within a truly global team spanning Zurich, Switzerland and Pleasanton, California. /p /li lipInfluence both product design and manufacturing strategy early in the development process. /p /li lipWork with advanced electromechanical medical technology in a highly innovative environment. /p /li lipGrow your career within one of the world's leading healthcare companies. /p /li /ul h3The Best of Both Worlds /h3 pOur 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. /p pAt 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. /p h3BASE PAY DETAILS /h3 pThe base pay for this position is /p pN/A /p pIn specific locations, the pay range may vary from the range posted. /p h3JOB FAMILY: /h3 pManufacturing /p h3DIVISION: /h3 pHF Heart Failure /p h3LOCATION: /h3 pSwitzerland : Technoparkstrass 1 CH 8005 /p h3WORK SHIFT: /h3 pStandard /p h3TRAVEL: /h3 pNot specified /p h3MEDICAL SURVEILLANCE: /h3 pNot Applicable /p h3SIGNIFICANT WORK ACTIVITIES: /h3 pNot Applicable /p #J-18808-Ljbffr