Medical Device Engineer

You will join cross-functional project teams responsible for the design, development, industrialization, and lifecycle management of products that combine drugs and medical devices, with a particular focus on autoinjectors and safety syringes.

Your role will be to ensure that risk management dossiers and the associated design control documentation are well-structured, technically sound, traceable, and aligned with project schedules.

Responsibilities

• Draft, update, and maintain risk management documentation for autoinjectors and safety syringes (plans, analyses, evaluation files, traceability of risk controls, reports).
• Ensure consistency between hazard analyses, design FMEA, in-use risk analyses, and traceability matrices.
• Ensure that documentation aligns with applicable risk management principles, particularly ISO 14971, throughout the entire product lifecycle.
• Conduct gap analyses against technical documentation and regulatory submissions.
• Perform consistency, completeness, and traceability checks on risk management files and associated technical documents by cross-referencing sources (design inputs, test evidence, usability data, and complaints).
• Identify discrepancies, ambiguities, or inconsistencies that could impact design reviews, regulatory submissions, audits, or risk management conclusions.
• Collaborate with various stakeholders.
• Contribute to the development of templates and best practices, and participate in initiatives to standardize and digitize device documentation.

Criteria

• Bachelor’s or Master’s degree in engineering, life sciences, pharmaceutical sciences, technical writing, or a related field.
• Experience in writing or maintaining technical documentation for medical devices: risk management files, design control documentation, FMEA, usability documentation, or verification documentation.
• Experience in the development of autoinjectors.
• Strong knowledge of risk management principles according to ISO 14971, design controls, and regulated product development environments.
• Understanding of applicable regulatory frameworks: EU MDR, Article 117, GSPR, 21 CFR Part 820, 21 CFR Part 4, ISO 13485, and GMP requirements.
• Rigorous and detail-oriented, with the ability to ensure logical consistency, traceability, and completeness of documentation.

Offer

• - A attractive salary in line with the market and your experience;
• Salary package with very competitiveextra-legal benefits;
• - Optimum work-life balance thanks to 12 ADV days, sliding hours and homeworking possibilities;
• - Join a community of over 200 consultants in quality and regulatory affairs, with many social events organized throughout the year;
• - Training and workshops to develop/share your skills