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 Device manufacturing.
Role type
Manufacturing Engineer
Builds
Manufacturing processes and fixtures for medical devices
Domain
Medical Device Manufacturing
Required skills
cGMP compliance, FDA guidelines adherence, validation/qualification protocol generation, Engineering Change Order implementation, project management, fixture design
Preferred skills
Medical device industry experience, Injection Molding, Metal Stamping/forming, PCB manufacture, Manual and automated assembly, CAD (ProEngineer/Solidworks), MS Project/Statgraphics
Technologies
ProEngineer, Solidworks, MS Office, MS Project, Statgraphics
Responsibilities
Maintain cGMP compliant environment, drive product and process improvements, generate validation/qualification protocols, author and implement Engineering Change Orders, design manufacturing fixtures, support project phases from concept to implementation
Seniority
Mid-level, hands-on IC