Medical Device Documentation & Quality Engineer

BioTalent; Turnhout; Sur place; EUR 42 000 - 68 000; Plein temps

Résumé du poste

BioTalent partners exclusively with SciPharm to pursue implantable infusion device programs. The Design & Development Engineer will contribute to all design and regulatory activities for the IIP and related products, ensuring quality and lifecycle compliance.

The role involves cross-functional collaboration with QA/RA and Manufacturing, processing external documentation, and maintaining DHF/TD/MDF with traceability. Excellent English is required; Dutch is a plus.

Qualifications

• Bachelor’s or Master’s in Engineering or Technical Sciences.
• 2–3 years in technical documentation, quality, or regulatory roles in medical devices.
• Solid DHF/TD/MDF knowledge under FDA 21 CFR Part 820, MDR EU 2017/745 and ISO 13485.
• Experience with implantable or Class II/III devices is a plus.
• Strong English communication; Dutch proficiency is an advantage.

Responsabilités

• Review and process external documents from D&D partners for DHF/TD/MDF.
• Evaluate documents for regulatory validity against FDA/MDR/ISO 13485.
• Identify gaps and formulate questions to improve document quality.
• Coordinate conversion/formatting of external docs to internal templates.
• Produce technical documentation for in-house development activities.
• Maintain DHF/TD/MDF with traceability and version control.
• Support ISO 14971 risk management files with QA/RA collaboration.
• Assist clinical investigations documentation.
• Collaborate with QA/RA and Manufacturing.
• Support audits, NCRs, CAPAs; contribute to a small agile team.
• Communicate with stakeholders in English; Dutch where applicable.

Connaissances

Technical docs

Regulatory compliance

DHF/TD/MDF

FDA 21 CFR 820

MDR EU 2017/745

ISO 13485

Risk management ISO14971

Usability IEC62366

English communication

Dutch proficiency

Formation

Bachelor’s or Master’s in Engineering or Technical Sciences

Outils

MS Office

eQMS

Description du poste

BioTalent partners exclusively with SciPharm to pursue implantable infusion device programs. The Design & Development Engineer will contribute to all design and regulatory activities for the IIP and related products, ensuring quality and lifecycle compliance.

The role involves cross-functional collaboration with QA/RA and Manufacturing, processing external documentation, and maintaining DHF/TD/MDF with traceability. Excellent English is required; Dutch is a plus.