Medical Device Engineer
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Location:
Braine-l’Alleud, Belgium or Bulle, Switzerland (hybrid working model) Engagement Status: Consulting Opportunity until March 2027 Overview We are partnered with a global pharmaceutical company seeking an experienced Medical Device Engineer to support the development and lifecycle management of drug-device combination products. Working within cross-functional technical project teams, you will take ownership of risk management documentation for autoinjector and safety syringe programmes. The role requires someone who can translate complex technical information into clear, consistent and inspection-ready documentation. You will collaborate closely with Device, Quality, Safety, Regulatory, Human Factors and Project stakeholders, helping to ensure that risk management files and supporting design control documentation are technically accurate, traceable and aligned with programme timelines. Requirements
- Author and maintain risk management files and design control documentation.
- Support risk analyses, FMEAs and traceability activities.
- Conduct documentation reviews, gap assessments and consistency checks.
- Collaborate with Quality, Regulatory, Safety and Device SMEs.
- Support continuous improvement of documentation processes and standards. Hard Skills
- Autoinjector development experience (essential).
- Strong knowledge of ISO 14971 and risk management principles.
- Experience with design controls, FMEAs and technical documentation.
- Familiarity with EU MDR, ISO 13485, GMP and related regulatory requirements.
- Strong technical writing and documentation skills. Soft Skills
- Highly organised and detail-oriented.
- Strong stakeholder management and communication skills.
- Able to manage multiple priorities and deadlines.
- Collaborative, proactive and solution-focused. Qualifications
- Bachelor's or Master's degree in Engineering, Life Sciences or a related discipline.
- 8+ years of experience within medical devices, pharmaceuticals or combination products.
- Experience working in regulated product development environments.
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