Head of Design

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