Senior NPI Engineer

Abbott seeks a Senior NPI Engineer in Zurich to lead manufacturing scale-up for the CentriMag system, bridging design and production for complex electro-mechanical devices.

This position focuses on advancing the next-generation CentriMag Circulatory Support System from concept to commercial reality. The engineer will manage the transition of intricate electromechanical medical devices into validated manufacturing, serving as a key liaison between teams in Zurich and the United States to ensure seamless production readiness.

Responsibilities

• Lead manufacturing process development from initial design stages through final commercial launch for sophisticated electro-mechanical medical devices.
• Develop, characterize, and refine production methods for capital equipment, covering assembly, testing, calibration, and packaging.
• Collaborate with R&D, Quality, and Operations teams to execute Design for Manufacturability (DFM) initiatives.
• Convert design specifications into actionable manufacturing requirements, equipment standards, and process documentation.
• Manage process validation activities (IQ/OQ/PQ) for internal tools and supplier processes, ensuring adherence to ISO 13485 and company protocols.
• Draft validation plans, protocols, and summary reports.
• Produce manufacturing documentation, including requirements, specifications, work instructions, test methods, and PFMEAs.
• Act as the primary technical contact for external suppliers developing sub-assemblies or handling outsourced manufacturing steps.
• Evaluate supplier process flows, PFMEAs, control plans, and validation protocols.
• Harmonize internal and external manufacturing processes to optimize production efficiency.

Requirements

• Bachelor’s degree in Mechanical, Manufacturing, Electrical Engineering, or a related technical field.
• Minimum of five years in medical device NPI, manufacturing engineering, or process development.
• Proven track record in developing and validating manufacturing processes and tooling for electro-mechanical or capital medical equipment.
• Solid understanding of process validation (IQ/OQ/PQ) within regulated manufacturing settings.
• Experience in creating manufacturing requirements, specifications, and procedures, including defining CTQs and IPCs.
• Practical experience on the manufacturing floor supporting engineering and pilot builds.
• Background in collaborating with and managing external suppliers for manufacturing processes or sub-assemblies.
• Strong technical writing and communication abilities, with capacity to work effectively in cross-functional teams.
• Fluency in English is mandatory.

Nice to have

• Experience with medical devices or equipment featuring electronics, motors, LCD displays, and user interface components.
• Proficiency in statistical analysis, including gage R&R, DOE, capability studies (Cp/Cpk), and other methods.
• Familiarity with Lean Manufacturing and/or Six Sigma methodologies.
• Experience supporting production ramp-up and sustaining engineering post-launch.
• Sustaining engineering background, such as yield improvement, root cause investigations, and ongoing process optimization.
• Communicative German language skills are advantageous.

What the company offers

• Opportunity to contribute to meaningful work that directly impacts patients’ lives.
• Career growth opportunities within a global healthcare organization.
• Employment in a stable and future-focused industry.
• A collaborative and inclusive team culture.
• A modern workplace located in the heart of Zurich.
• An environment that values diverse perspectives and experiences.

About the company

Abbott fosters a workplace where employees feel supported, included, and empowered to perform at their best. The company is dedicated to creating an environment where everyone can succeed, valuing different perspectives and experiences.

• Employees thrive when they feel supported, included, and empowered.
• The company is committed to creating an environment where everyone can succeed.