Design Quality Engineer - Medical Devices, NPD & Risk Mgmt

Bien-Air Surgery; Biel; On-site; CHF 90,000 - 130,000; Full time

Benefits offered by this job

Family-oriented culture

Continuous learning opportunities

Job summary

Bien-Air Surgery in Switzerland is seeking a Design Quality Engineer for our Bienne site to support the development of medical devices and ensure design quality. You will collaborate across departments to guarantee compliance with internal QMS and external standards.

You will drive NPD and design changes, support design verification and validation, update MDR-aligned documentation, and contribute to risk management and product information materials.

Qualifications

• Bachelor’s degree in mechanical, micro-mechanical or biomedical engineering.
• 1–3 years’ experience in quality assurance of medical devices (class IIa or above).
• Knowledge of DMR and DHF structure and contents.
• Experience with ISO 13485 QMS and Risk Management for Medical Devices.
• Experience with EU MDR 2017/745.

Responsibilities

• Lead and support NPD and Design Changes by ensuring compliance of activities and documentation to internal QMS requirements and external regulations (FDA, ISO).
• Support Verification & Validation activities to ensure compliance with Design Control requirements.
• Generate and maintain Risk Management File during NPD and Design Changes using ISO 14971.
• Ensure quality assurance during all stages of product development under MDR requirements.
• Update product documentation to MDR requirements.
• Create, review or approve DMR and DHF documentation released during NPD and Design Changes.
• Contribute to User Information Material and to continuous improvement of internal procedures related to NPD, Design Change and Risk Management.
• Contribute to product reprocessing methodology and testing (cleaning and sterilization).

Skills

QA medical devices

DMR/DHF knowledge

ISO 13485

EU MDR 2017/745

MS Office

PLM

French (fluent)

English (B2)

Organizational skills

Teamwork

Education

Bachelor’s degree in mechanical/biomedical engineering

Tools

PLM system

Job description

Bien-Air Surgery in Switzerland is seeking a Design Quality Engineer for our Bienne site to support the development of medical devices and ensure design quality. You will collaborate across departments to guarantee compliance with internal QMS and external standards.

You will drive NPD and design changes, support design verification and validation, update MDR-aligned documentation, and contribute to risk management and product information materials.