Bachelor's or Master's degree in Engineering, Biomedical Engineering, Industrial Engineering, or a related technical discipline.
PMP, PRINCE2, IPMA, or equivalent project management certification
10+ years of progressive project management experience, including leadership of cross-functional teams within the medical device industry.
Proven track record of leading complex medical device development projects from concept through commercialization.
Experience working within outsourced development models and managing external development partners.
Experience operating in both European and US regulatory environments.
Strong understanding of medical device development processes, design controls, risk management, verification, and validation activities.
Solid knowledge of EU MDR, FDA medical device regulations, ISO 13485, ISO 14971, and product lifecycle management principles.
Experience with manufacturing transfer, supplier management, and commercialization activities.
Strong strategic leadership, stakeholder management, negotiation, and organizational change management skills.
Fluent English (C1/C2) with excellent communication and influencing abilities.
