Head of Design & Development

BioTalent; Turnhout; Sur place; EUR 120 000 - 160 000; Plein temps

Résumé du poste

BioTalent is partnering with SciPharm to appoint a Head of Design & Development responsible for SciPharm’s Implantable Infusion Pump (IIP) and related products. You will bridge scientific and engineering excellence, regulatory compliance, and business strategy, leading the D&D team across internal engineers and CROs.

Key requirements include a Master’s degree in Engineering, 8+ years in medical device D&D with leadership, deep knowledge of FDA/EU design controls, risk management per ISO 14971,

Qualifications

• Master’s degree or higher in Engineering or Technical Sciences.
• Minimum 8 years of medical device D&D experience, including 3+ years in leadership.
• Deep knowledge of FDA 21 CFR Part 820, EU MDR (2017/745) and ISO 13485 design controls.
• Experience with DHF/TD/MDF structure and lifecycle documentation.
• Experience with ISO 14971 risk management and IEC 62366 usability engineering.
• Experience managing external CROs or development partners.
• Excellent written and verbal English; Dutch is an advantage.
• Strong stakeholder management and cross-functional collaboration.
• Comfortable in a small-team environment; hands-on ownership.
• MS Office proficiency; eQMS/document management experience is a plus.

Responsabilités

• Lead, manage and develop the D&D team and coordinate external partners and CROs.
• Ensure compliance with FDA 21 CFR Part 820, EU MDR and ISO 13485 and associated design controls.
• Own Design History File, Technical Documentation and Manufacturing Documentation File lifecycle.
• Oversee design input/output, verification and validation with risk management alignment.
• Manage external partners and integrate documentation into the QMS with quality standards.
• Drive clinical investigations and collaborate with clinical/regulatory teams for data packages.
• Coordinate regulatory submissions, notified body interactions and post-market obligations.
• Work with Manufacturing to transfer designs and processes, preparing transfer docs.
• Represent D&D in leadership and with regulatory bodies, clinicians, and suppliers.
• Support other activities in a small, agile organisation as needed.

Connaissances

Leadership

Stakeholder management

English proficiency

Hands-on attitude

MS Office

eQMS familiarity

Formation

Master’s degree in Engineering or Technical Sciences

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 Head of Design & Development to lead all design and development activities for SciPharm’s Implantable Infusion Pump (IIP) and related products. This role is the bridge between scientific and engineering excellence, regulatory compliance, and business strategy.

Responsibilities

• Lead, manage and develop the D&D team, including internal engineers and the coordination of external development partners and contract research organisations (CROs).
• Ensure that all design and development activities are conducted in full compliance with FDA 21 CFR Part 820, EU MDR (2017/745) and ISO 13485, including design controls, design reviews, verification and validation.
• Take ownership of the Design History File (DHF), Technical Documentation (TD) and Manufacturing Documentation File (MDF), ensuring completeness, traceability, and version control throughout the product lifecycle.
• Oversee design input, design output, design verification and design validation activities, ensuring alignment with risk management requirements per ISO 14971.
• Manage relationships with third‑party development partners, reviewing and integrating externally generated documentation into the company’s QMS with rigorous quality standards.
• Drive and oversee clinical investigation activities, working closely with clinical and regulatory functions to ensure appropriate documentation and data packages.
• Collaborate with QA/RA on regulatory submissions, notified body interactions, and post‑market surveillance obligations, ensuring D&D provides the required technical inputs.
• Work closely with the Head of Manufacturing to ensure a smooth transfer of designs and processes to manufacturing, including the preparation of relevant transfer documentation.
• Represent D&D within the leadership team and with key external stakeholders, including regulatory bodies, clinical partners, and suppliers.
• Support other activities as needed, contributing to other processes in line with the needs of a small, agile organisation.

Qualifications & Experience

• Master’s degree or higher in Engineering or Technical Sciences.
• Minimum 8 years of relevant experience in medical device D&D, of which at least 3 years in a leadership or senior technical role.
• Deep knowledge of FDA 21 CFR Part 820, EU MDR (2017/745) and ISO 13485 design control requirements.
• Solid understanding of DHF/TD/MDF structure and content requirements, and experience managing these files throughout the product lifecycle.
• Experience with risk management per ISO 14971 and usability engineering per IEC 62366.
• Following items are considered a strong advantage:
• Experience with active implantable medical devices under EU MDR or PMA devices under FDA.
• Experience leading or contributing to clinical investigations or IDEs.
• Experience managing external CROs or development partners.
• Excellent written and verbal communication skills in English; Dutch language proficiency is a significant advantage.
• Strong stakeholder management skills, capable of engaging constructively with regulatory bodies, clinical partners, and cross‑functional internal teams.
• 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.