Design And Development 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 is currently partnered exclusively with SciPharm, part of AOP Health Group. SciPharm specialises in implantable infusion products, one of only 5 medical device businesses currently in development/use in the world.

As part of their current rapid expansion, they are looking for a Design & Development Engineer to participate in in all design and development activities for SciPharm’s Implantable Infusion Pump (IIP) and related products. This role is essential to maintaining our product quality and regulatory compliance throughout the product lifecycle.

Responsibilities

• Review, assess, and process external technical documents received from third-party D&D partners for incorporation into the DHF/TD/MDF.
• Evaluate documents for regulatory validity and completeness against FDA 21 CFR Part 820, MDR (EU 2017/745) and ISO 13485 requirements.
• Identify gaps or deficiencies in external documentation and formulate targeted, constructive questions to third parties to drive document improvement.
• Coordinate the conversion and formatting of external documents to align with internal QMS templates and document control standards.
• Produce technical documentation for development activities that are not outsourced.
• Maintain and update the DHF/TD/MDF throughout the product lifecycle, ensuring traceability and version control.
• Support risk management activities by maintaining and updating risk management files in accordance with ISO 14971, in close cooperation with QA/RA.
• Support the clinical team with the documentation required for clinical investigations.
• Collaborate closely with cross-functional teams including QA/RA and Manufacturing.
• Support QA activities as needed, contributing to audits, NCRs, CAPAs, and other quality processes in line with the needs of a small, agile organisation.
• Communicate proactively and professionally with internal stakeholders and external partners in English and, where applicable, in Dutch.

Qualifications & Experience

• Bachelor’s or Master’s degree in Engineering or Technical Sciences.
• Minimum 2–3 years of experience in a technical documentation, quality, or regulatory role within the medical device industry.
• Solid understanding of DHF/TD/MDF structure and content requirements under FDA 21 CFR Part 820, MDR (EU 2017/745) and ISO 13485.
• Experience in working with or reviewing documentation for implantable or Class II/III medical devices is a strong advantage.
• Familiarity with risk management per ISO 14971 and/or usability engineering per IEC 62366.
• Demonstrated ability to critically review technical documents and identify gaps or inconsistencies.
• Excellent written and verbal communication skills in English;
• Dutch language proficiency is a significant advantage.
• Strong attention to detail and a structured, methodical approach to document review.
• Understanding of design controls, verification and validation principles, and how these translate into documentation requirements.
• Ability to ask the right questions and engage constructively with external partners to improve document quality.
• Comfortable working in a small-team environment where flexibility and a hands-on attitude are essential.Collaborative team player who takes ownership and contributes beyond a strictly defined role when needed.
• Proficient in MS Office; experience with eQMS or document management systems is a plus.

About SciPharm

SciPharm is part of a group of companies that is active in the field of life-sciences. Within the group, the company specialises in the design & development and manufacturing of Medical Devices.

SciPharm developed an Implantable Infusion Pump (IIP), which is a class III active implantable device for the administration of Medication and is establishing a manufacturing unit in Turnhout (B). The main manufacturing processes involve laser welding of titanium parts and components with high-precision production equipment.