Sr. Mfg Engineer

Principal Mechanical Engineer – Direct – Lawrence, MA

Lead development of next generation capital equipment

Work with external industrial design teams and OEM manufacturers to develop electromechanical sub-systems.

Responsible for designing, building, and testing new concepts and iterating through the design process.

Demonstrate subsystem reliability including development of test fixtures and protocols.

Develop drawings and release documentation in accordance with applicable standards and SOPs.

Prepare documentation to support quality system for design functions (project plans, design input, risk assessment, test protocols and reports, drawing specifications, etc.)

BS in Mechanical Engineering, Plastics Engineering, Biomedical Engineering, or equivalent combination of education and experience

8+ years of product development experience as mechanical engineer with 4 years in a lead role for complex Class II or III medical capital equipment.

Expert in Solidworks 3D modeling and design of injection molded, machined, and sheet metal components.

Solid foundation of mechanical engineering fundamentals and ability to perform detailed engineering analysis including tolerance analysis & FEA.

Knowledgeable in plastic joining techniques including ultrasonic/RF/laser welding and adhesive/solvent bonding.

Strong hands-on skills and ability to use power tools and light machine shop equipment.

Strong written and verbal communication skills are required.

Understanding of medical device development processes including experience with FDA CFR 820 and ISO 13485 regulations.

Previous experience with IEC 60601-1 mechanical design requirements is strongly preferred.

Prior project management experience and Six Sigma Green Belt desired.