Engineering

Design Quality Engineer

  • Location

    Münchendorf

  • Sector:

    Medical Devices

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Max Jones

  • Contact email:

    m.jones@ioassociates.eu

  • Job ref:

    BBBH160265_1747142405

Advanced Design Quality Engineer - MedTech Start-up
Permanent | Hybrid | Start ASAP

I'm supporting a high-growth MedTech start-up developing advanced imaging technologies that combine hardware, software, and AI to address critical clinical needs.

They're looking for a permanent Advanced Design Quality Engineer to ensure regulatory compliance across the full product lifecycle and support R&D, Regulatory Affairs, and Manufacturing teams.

Key Responsibilities:

  • Ensure compliance with ISO 13485, 14971, 62304, 62366, 60601, and FDA QSR

  • Lead risk management (FMEA, hazard analysis) and support design V&V

  • Contribute to technical documentation, labelling, and design reviews

  • Support CAPA, change control, internal audits, and software/electrical safety compliance

  • Provide input on AI and cybersecurity considerations for medical devices

Ideal Profile:

  • 4+ years of quality experience in medical devices

  • Strong knowledge of international standards and regulatory frameworks

  • Experienced in V&V, risk tools, and cross-functional collaboration

  • Background in engineering, quality, or a related field