Sr. Manager, Process Engineering
Core
Lead Process Engineering team in Penang, Malaysia to define and implement strategic vision for Instruments and Accessories manufacturing, ensuring production, quality, and efficiency for robotic procedures worldwide.
Role type
Senior Manager, Process Engineering
Builds
Instruments and Accessories for robotic surgical procedures
Domain
Medical Device Manufacturing / Robotic Surgery
Required skills
Process validation (DQ/IQ/OQ/PQ/PPQ), Statistical Process Control (SPC), Design of Experiments (DoE), Failure Mode and Effects Analysis (FMEA), Capacity planning, Team leadership, Budgeting, Data analytics
Preferred skills
Medical device Design Control, ISO 13485/ISO 9001 environment experience, Surgical instrument clinical application knowledge
Technologies
Microsoft Office suite, Data analytics tools
Responsibilities
Lead Manufacturing and Equipment Engineering teams, Execute multi-year capacity improvement roadmap, Oversee equipment validation and qualification, Maintain medical device quality system compliance, Manage team hiring, training, and development, Define and maintain KPIs using data analytics, Partner with cross-functional teams for operational excellence
Seniority
Senior, hands-on IC with management responsibilities