Sr Operations & NPI Engineer

Thoratec Switzerland GmbH; Zürich; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Thoratec Switzerland GmbH is seeking a Senior Operations & NPI Engineer to lead industrialization, validation, and scale-up of complex electromechanical medical devices. The role bridges Zurich and Pleasanton, partnering with R&D, Quality, Regulatory, and Suppliers to bring products from development to launch.

You will own process validation, design transfer, and manufacturing readiness, ensuring robust processes and successful commercialization across global teams.

Qualifikationen

• 7+ years in New Product Introduction, Manufacturing Engineering, or Design Transfer in a regulated industry.
• Experience developing and validating manufacturing processes for complex electromechanical products.
• Strong knowledge of process validation methodologies (IQ/OQ/PQ) and manufacturing readiness.
• Experience with PFMEAs, control plans, CTQs, and IPCs.
• Hands-on supervision of engineering builds, pilot production, and manufacturing floor activities.

Aufgaben

• Lead New Product Introduction and manufacturing scale-up from concept through commercial launch.
• Develop, characterize, optimize, and scale manufacturing processes for assembly, calibration, testing, inspection, and packaging.
• Drive Design for Manufacturability (DFM) and DFA improvements with R&D.
• Translate product requirements into manufacturing specifications, process specs, equipment needs, and control strategies.
• Support engineering builds, pilot builds, clinical builds, and ramp-up activities.
• Own process validation activities (IQ/OQ/PQ) for internal and supplier processes.

Kenntnisse

NPI/Manufacturing Eng

DFM/DFA

IQ/OQ/PQ

Design transfer

English fluency

Manufacturing scale-up

Communication skills

Ausbildung

Bachelor's degree in Electrical Engineering

Jobbeschreibung

Sr Operations & NPI Engineer

Thoratec Switzerland GmbH Vacant since : 03.09.2026 Number of jobs : 1 8005 Zürich (ZH) 100% By agreement Permanent

Senior Operations & 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 Circulatory Support Systems from development into global manufacturing.

As a Senior Operations & 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-upfrom early development through commercial launch.

A unique aspect of this position is the close collaboration between our teams inZurich, 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'dlove 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.
• Developvalidationplans, 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 inElectrical Engineering, Mechatronics,Mechanical Engineering, ManufacturingEngineeringora relatedengineering 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, andIPCs.
• Hands-on experience supporting engineering builds, pilot production, and manufacturing floor activities.
• Experience collaborating with external suppliers and contract manufacturers.
• Strong communicationand 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.
• Proficiencywith 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.
• Workwith 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 approximately160 employees, offering the visibility, ownership, agility, and family-likeculture oftenassociated 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 ofAbbott's global organization, collaborating closely with teams in Pleasanton, California and around the world whilebenefitingfrom the resources, stability, technology leadership, and career opportunities of one of the world's leading healthcare companies.

• Work location 8005 Zürich (ZH)
• Workload 100%
• Employment start By agreement
• Employment duration Permanent

• English Orally : Very good knowledge Written : Very good knowledge

• By online Online form