Manufacturing Engineer (Onsite - Acton, MA)
Core
Engineering work to plan, devise, and adapt methods to improve process effectiveness at captive and third-party manufacturing sites for Class II medical devices.
Role type
Manufacturing Engineer
Builds
Manufacturing fixtures, validation/qualification protocols, and engineering change orders for medical device production.
Domain
Medical Device Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, FDA guidelines adherence, validation/qualification protocol generation, engineering change order implementation, project management, fixture design
Preferred skills
Injection molding, metal stamping, PCB manufacture, manual/automated assembly, CAD (ProEngineer/Solidworks), MS Project/Statgraphics
Responsibilities
Maintain cGMP compliant environment, drive product/process improvements via CAPA system, generate and execute validation protocols, author engineering change orders, design manufacturing fixtures, support project phases from concept to implementation
Seniority
Mid-level, hands-on IC
