Design And Development Engineer

BioTalent; Turnhout; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

BioTalent is partnering with SciPharm to recruit a Design & Development Engineer for the Implantable Infusion Pump program in Turnhout, Belgium. You will participate in design, documentation, and regulatory activities to ensure product quality throughout the lifecycle.

You will review external documents, prepare DHF/TD/MDF content, support ISO 13485, MDR compliance, and collaborate with QA/RA and Manufacturing. Proficiency in English required; Dutch a plus.

Qualifications

• Bachelor's or Master's degree in Engineering or Technical Sciences.
• 2-3 years in technical documentation, quality, or regulatory roles in medical devices.
• Knowledge of DHF/TD/MDF structures under FDA 21 CFR Part 820, MDR, ISO 13485.

Responsabilités

• Review external documents from third parties for DHF/TD/MDF incorporation.
• Evaluate regulatory validity against FDA MDR and ISO 13485 requirements.
• Identify gaps and ask targeted questions to improve documents.
• Coordinate conversion of external docs to internal templates and control standards.
• Produce technical documentation for activities not outsourced.
• Maintain DHF/TD/MDF with traceability and version control.
• Support ISO 14971 risk management with QA/RA collaboration.
• Assist clinical investigations documentation with the clinical team.
• Collaborate with QA/RA and Manufacturing; support audits and CAPAs.
• Communicate with stakeholders in English; Dutch is a plus.

Connaissances

Regulatory compliance

Documentation review

Cross-functional collaboration

Attention to detail

English communication

Process improvement

Formation

Bachelor's or Master's degree in Engineering or Technical Sciences

Outils

MS Office

eQMS

Description du poste

Design & Development Engineer

Location: Turnhout, Belgium

Contract: Permanent, full-time

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 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.

Skills & Competencies:

• 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.