Chief Design & Development Leader

SciPharm SARL; Turnhout; Presencial; EUR 120.000 - 180.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Leadership

Medical device D&D

Regulatory knowledge

Documentation management

Risk management

Usability engineering

External partners management

Educación

Master's in Engineering

Descripción del empleo

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.