Senior NPI Engineer

Senior NPI Engineer New Product Introduction

Abbott is seeking a Senior New Product Introduction (NPI) Engineer to support the development and manufacturing scaleup of the nextgeneration CentriMag Circulatory Support System. This role will be a key contributor to transitioning complex electromechanical medical devices from design through validated manufacturingboth inhouse and at external suppliers.

The ideal candidate brings handson experience in process development process validation and manufacturing readiness for capital equipment containing electronics displays user interfaces (buttons touchscreens connectors) and electromagnetic motors within a regulated medical device environment.

With your work youll ensure these life-saving products stay at the forefront of innovation and meet the highest standards of our your role you will be interfacing and collaborating with cross-functional teams in Zurich and United States offices.

Main Responsibilities

New Product Introduction & Process Development

• Drive manufacturing process development from early design phases through commercial launch for complex electromechanical medical devices.

• Develop characterize and optimize manufacturing processes for capital equipment including assembly test calibration and packaging operations.

• Support Design for Manufacturability (DFM) activities in collaboration with R&D Quality and Operations.

• Translate design requirements into manufacturing requirements equipment specifications and process documentation.

Process Validation & Manufacturing Readiness

• Own process validation activities (IQ/OQ/PQ) for inhouse equipment and supplier processes in compliance with ISO 13485 and Abbott procedures.

• Author validation plans protocols and summary reports.

• Create manufacturing documentation including manufacturing requirements equipment and process specifications manufacturing procedures/work instructions/IPCs test methods and PFMEAs.

Manufacturing & Supplier Collaboration

• Serve as the technical interface between Abbott and external suppliers developing subassemblies or performing outsourced manufacturing steps.

• Review supplier process flows PFMEAs control plans and validation protocols.

• Align internal and external manufacturing processes for efficient production.

Required Qualifications

• Bachelors degree in Mechanical Engineering Manufacturing Engineering Electrical Engineering or a related technical discipline.

• 5 years of experience in medical device NPI manufacturing engineering or process development.

• Ownership in developing and validating manufacturing processes and tooling for electromechanical or capital medical equipment.

• Strong working knowledge of process validation (IQ/OQ/PQ) and regulated manufacturing environments.

• Experience creating manufacturing requirements specifications and procedures including developing/defining CTQs and IPCs

• Hands-on experience on the manufacturing floor to support engineering/pilot builds.

• Experience collaborating with and managing external suppliers for manufacturing processes or subassemblies.

• Strong technical writing and communication skills; ability to collaborate with a cross-functional project team (R&D Quality Regulatory etc.)

• English proficiency is required (English is used in meetings and all documentation)

Preferred Qualifications

• Experience with medical devices/equipment containing electronics motors LCD displays and user interface components

• Proficiency using statistics including gage R&R DOE capability studies (Cp/Cpk) and other analyses to ensure measurement and process robustness

• Experience with Lean Manufacturing and/or Six Sigma methodologies

• Experience supporting production rampup and sustaining engineering after product launch

• Sustaining experience post-launch e.g. yield improvement root cause investigations and ongoing process optimization

• Communicative German is a plus

Why Join Abbott / Thoratec

At Abbott we know that people do their best work when they feel supported included and empowered. We are committed to creating an environment where everyone can succeed.

You can expect:

• Meaningful work that directly impacts patients lives

• Career growth opportunities within a global healthcare organization

• A stable and future-focused industry

• A collaborative and inclusive team culture

• A modern workplace in the heart of Zurich

• An environment where different perspectives and experiences are valued

Ready to Apply

Were looking for curious motivated people who want to grow and make a difference not just those who meet every single requirement.

If this role sounds exciting to you wed love to hear from you.