Industry leading medical devices company seeks an Engineering Manager to lead a process development and tech transfer team in the development of a new Class III electromechanical implantable medical device.
The engineering manager will be responsible for partnering with an internal teams and contract manufacturing to develop and execute the transfer strategy and select a larger CMO once the product is commercial. Initially anticipated travel will be 40% both domestic and international.
Our medical device clients seek engineering management leaders who are career-driven, have strong management and mentoring skills and a depth of experience in managing complex tech transfer projects. Our companies offer excellent career growth potential, and excellent benefits. We have many opportunities – all with top medical device companies seeking the best in engineering leadership.
typical roles and responsibilities for Engineering Manager
Develop and execute project operations integration plan
Manage pilot production builds
Plan and manage manufacturing budget, including capital and operating expenses
Develop, execute and own process validation plan
Manage manufacturing risk assessment and mitigations, through hands on work and developing action plans
Requirements for the Engineering Manager – Medical Devices
Bachelor’s degree in engineering, preferred disciplines would include mechanical engineering, manufacturing engineering or industrial engineering. Advanced degree preferred
8+ years of progressive experience leading medical device tech transfer projects, scale up from pilot to full manufacturing production
Experience supporting the manufacture of electro-mechanical medical devices
A track record of accomplishment in developing production process requirements, specifications.
Experience working with design firms and contract manufacturing and operations to develop best production systems
Experience identifying and developing contract manufacturing partners strongly preferred
Strong project management experience
Demonstrated excellence in moving medical devices through design transfer to operations (full manufacturing)
A technical background strong in manufacturing engineering, including DFM (Design for Manufacturability, process excellence methodologies, Six Sigma, Lean, supplier development and process validation. Experience in design control and various country regulations, including FDA and EU
Strong analytical, organizational and leadership skills and a track record of accomplishment working with influencers and cross functional teams
The ability to travel up to 40% both domestic and international