Senior Design Assurance Engineer – MedTech (HW & SW)

Randstad Switzerland; Neuenburg; Vor Ort; CHF 110.000 - 160.000; Vollzeit

Zusammenfassung

Randstad Switzerland partners with a MedTech scale-up to recruit a Senior Quality Engineer (Design Assurance) to lead design controls, risk management, and quality compliance across the product lifecycle.

Role requires 5+ years in Quality Engineering in medical devices, with hands-on Design V&V, DHF management, and change controls for SaMD/hardware. Occasional on-site in Neuchâtel, Switzerland. Proficiency with ISO 13485/14971, FDA 21 CFR 820, EU MDR and IEC standards expected.

Qualifikationen

• 5+ years in Quality Engineering or Design Assurance within the medical device industry.
• Strong working knowledge of ISO 13485, ISO 14971, FDA 21 CFR 820 / QMSR, EU MDR, and active/software standards (IEC 62304, IEC 60601, IEC 62366).
• Hands-on expertise in Design V&V, DHF management, and change controls for medical hardware and software (SaMD).
• Location: Resident in Switzerland with the flexibility for occasional on-site presence in Neuchâtel.

Aufgaben

• Design Assurance Leadership: Drive Design Controls, Risk Management, Design Reviews, and Design Transfer for product development and sustaining projects.
• Technical Documentation: Review and maintain complete, compliant DHFs and Technical Documentation.
• Cross-Functional Collaboration: Partner with R&D, Software, Systems Engineering, Clinical, and Regulatory teams from concept through commercialization.
• Audit Subject Matter Expert: Serve as the Design Assurance SME during Notified Body audits and FDA inspections.

Kenntnisse

Quality engineering

Design Assurance

Design Controls

Risk Management

Regulatory Compliance

Design V&V

DHF management

Jobbeschreibung

Senior Quality Engineer - Design Assurance (m/f/d)

Contract: permanent

We are partnering with an innovative, high-growth MedTech Scale-up developing cutting-edge connected medical devices (wearable hardware + digital health software/app).

They are looking for a Senior Quality Engineer (Design Assurance) to lead Design Controls, Risk Management, and quality compliance throughout the product development lifecycle.

Key Responsibilities

• Design Assurance Leadership: Drive Design Controls, Risk Management (ISO 14971), Design Reviews, and Design Transfer for new product development and sustaining engineering projects.
• Technical Documentation: Review and maintain complete, compliant, and inspection-ready Design History Files (DHFs) and Technical Documentation.
• Cross-Functional Collaboration: Partner closely with R&D, Software, Systems Engineering, Clinical, and Regulatory teams from concept through commercialization.
• Audit Subject Matter Expert: Serve as the Design Assurance SME during Notified Body audits and FDA inspections.

Requirements

• Experience: 5+ years in Quality Engineering or Design Assurance within the medical device industry.
• Standards & Regulations: Strong working knowledge of ISO 13485, ISO 14971, FDA 21 CFR 820 / QMSR, EU MDR, and active/software standards (IEC 62304, IEC 60601, IEC 62366).
• Technical Scope: Hands-on expertise in Design V&V, DHF management, and change controls for medical hardware and software (SaMD).
• Location & Mobility: Resident in Switzerland with the flexibility for occasional on-site presence in Neuchâtel.