NPI Engineer, Medical Devices & Automation

agap2 Switzerland; Zürich; On-site; CHF 120,000 - 180,000; Full time

Job summary

agap2 Switzerland is seeking a passionate professional to drive manufacturing process development from early design through commercial launch. You will develop and optimize assembly, calibration, and automated test processes while coordinating with R&D, Quality, Regulatory, and Operations to ensure manufacturability and regulatory compliance.

You will lead equipment qualification, PFMEA/audits, and documentation, while partnering with external suppliers to align processes and deliver efficient,

Qualifications

• Bachelor’s degree in Electrical Engineering, Manufacturing Engineering, or a related technical field.
• Five+ years of experience in medical device NPI, manufacturing engineering, or process development.
• Hands-on experience designing and developing automated manufacturing test systems.
• Practical prototyping experience.
• Experience developing and validating manufacturing processes and tooling for electromechanical devices or capital equipment.
• Strong understanding of process validation (IQ/OQ/PQ) and regulated manufacturing.
• Experience preparing manufacturing requirements, specifications, procedures, CTQs, and IPCs.
• Experience supporting engineering or pilot builds on the manufacturing floor.
• Experience working with external manufacturing suppliers.
• Strong technical writing and communication skills, with the ability to collaborate across R&D, Quality, Regulatory, and Operations.
• Professional proficiency in English; German is an advantage.

Responsibilities

• Drive manufacturing process development from early design through commercial launch, coordinating with internal teams and external suppliers.
• Develop, characterize, and optimize assembly, calibration, and automated test processes.
• Support Design for Manufacturability (DFM) activities with R&D, Quality, and Operations.
• Translate design requirements into manufacturing requirements, equipment specifications, and process documentation.
• Develop and qualify complex manufacturing equipment, including test systems and tooling.
• Support process validation (IQ/OQ/PQ) for internal equipment and supplier processes.
• Prepare validation plans, protocols, reports, work instructions, test methods, and PFMEAs.
• Define manufacturing requirements, process specifications, CTQs, and in-process controls (IPCs).
• Support engineering and pilot builds on the manufacturing floor.
• Coordinate with external suppliers and review their PFMEAs, control plans, and validation documentation.
• Help align supplier and internal processes to support efficient, compliant production.

Skills

Automated test systems development

Prototyping

Manufacturing process development

IQ/OQ/PQ validation

Manufacturing specifications & CTQs

External suppliers

Technical writing

English proficiency

Education

Bachelor’s degree in Electrical/Manufacturing Engineering or related

Job description

agap2 Switzerland is seeking a passionate professional to drive manufacturing process development from early design through commercial launch. You will develop and optimize assembly, calibration, and automated test processes while coordinating with R&D, Quality, Regulatory, and Operations to ensure manufacturability and regulatory compliance.

You will lead equipment qualification, PFMEA/audits, and documentation, while partnering with external suppliers to align processes and deliver efficient,