The role leads a team responsible for sustaining, improving, and scaling robust manufacturing processes for neurovascular products in a regulated medtech environment
Job Summary
The role leads a team responsible for sustaining, improving, and scaling robust manufacturing processes for neurovascular products in a regulated medtech environment.
Candidates must demonstrate a proven track record of delivering performance improvements in yield, scrap, cycle time, quality, capacity, and cost.
The position requires driving New Product Introduction transfers, validation, automation, and capital deployment while ensuring full compliance with EU MDR, ISO 13485, and FDA QMSR requirements.
Matching Summary
The role leads a team responsible for sustaining, improving, and scaling robust manufacturing processes for neurovascular products in a regulated medtech environment.
Skills & Requirements
Must-have
10+ years regulated manufacturing experience
5+ years senior management experience
GMP and FDA regulatory compliance knowledge
Lean Six Sigma process improvement
NPI transfer and validation leadership
Capital equipment specification and budgeting
Nice-to-have
Strong stakeholder negotiation skills
Cross-functional team collaboration
Continuous learning culture champion
Technological automation pioneer
Inclusive team environment builder
Key Requirements
Degree or Masters in Engineering or Science
Minimum 10 years relevant experience
Ideally 5+ years at senior/management level
Knowledge of GMP/FDA regulations
Health and Safety Regulations legislation knowledge