Director – Device Engineering (MSAT)
Core
Strategic and technical leadership for device and combination product industrialization, ensuring manufacturability, compliance, and successful global commercial launches.
Role type
Director, Device Engineering (MSAT)
Builds
Scalable, compliant device manufacturing strategies and industrialization processes for medical devices and combination products.
Domain
Medical Devices / Combination Products / Manufacturing Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Device design and assembly, Manufacturing process development and validation, Regulatory compliance (ISO 13485, 21 CFR Part 820), Technology transfer, Cross-functional matrix leadership, Strategic roadmap development, Risk management (pFMEA), Process characterization and control, Talent development and mentoring.
Preferred skills
Advanced manufacturing technologies, Automation and digital tools, Data analytics for process control, Industry benchmarking.
Technologies
IQ/OQ/PQ, CPV, pFMEA, Design History Files (DHF), Design Master Records (DMR), Automation systems, Inspection systems.
Responsibilities
Define and implement device engineering and industrialization strategy, Oversee end-to-end device industrialization and technology transfer, Establish validation strategies and govern process control, Ensure compliance with global regulatory requirements, Act as global SME for device engineering, Develop training strategies and build organizational capability.
Seniority
Director, strategic & organizational leadership
