Head of Design & Development

SciPharm SARL; Turnhout; On-site; EUR 120,000 - 180,000; Full time

Job summary

SciPharm SARL in Turnhout, Belgium, seeks a Head of Design & Development to lead all design and development activities for implantable devices, ensuring regulatory compliance and quality across the DHF, TD and MDF.

You will manage internal engineers and CROs, drive risk management per ISO 14971, and coordinate documentation through the product lifecycle, including transfer to manufacturing and regulatory submissions.

Qualifications

• Master's degree in Engineering or Technical Sciences.
• 8+ years of relevant experience in medical device D&D, with at least 3 years in leadership.
• Deep knowledge of FDA 21 CFR Part 820, EU MDR (2017/745) and ISO 13485 design control requirements.
• Experience managing DHF/TD/MDF structure and lifecycle documentation.
• Experience with ISO 14971 risk management and IEC 62366 usability engineering.

Responsibilities

• Lead, manage and develop the D&D team, including internal engineers and coordination of external partners.
• Ensure all design and development activities comply with FDA 21 CFR Part 820, EU MDR and ISO 13485, including design controls and design reviews.
• Own DHF/TD/MDF, ensuring completeness, traceability and version control.
• Oversee design inputs/outputs, verification and validation aligned with risk management per ISO 14971.
• Manage relationships with external development partners and CROs.
• Drive clinical investigation activities with clinical/regulatory functions for documentation and data packages.
• Collaborate with QA/RA on regulatory submissions, notified bodies and post-market obligations.
• Coordinate transfer of designs to manufacturing and prepare transfer documentation.
• Represent D&D in leadership and with regulatory bodies, clinical partners and suppliers.
• Support other processes in a small, agile organization and communicate in English and Dutch where applicable.

Skills

Leadership

Medical device D&D

Regulatory knowledge

Documentation management

Risk management

Usability engineering

External partners management

Education

Master's in Engineering

Job description

The Head of Design & Development (D&D) leads 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. The Head of D&D oversees the work of internal D&D engineers and external development partners, steers the product portfolio through the full development lifecycle, and is ultimately responsible for the quality and regulatory completeness of the Design History File (DHF), Technical Documentation (TD), and Manufacturing Documentation File (MDF).

Responsibilities:

• Lead, manage and develop the D&D team, including internal engineers and the coordination of external development partners and contract research organizations (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 organization.
• Communicate proactively and professionally with internal stakeholders and external partners in English and, where applicable, in Dutch.

Qualifications

• 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:

• oExperience with active implantable medical devices under EU MDR or PMA devices under FDA.
• oExperience leading or contributing to clinical investigations or IDEs.
• oExperience managing external CROs or development partners.