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Principal Mechanical Engineer

Andover, MA 01810

Posted: 04/01/2023 Job Number: 32053

Job Description

  • Lead development of next generation capital equipment for the  product lines.
  • 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.)
  • Create development strategies and provide direction to junior engineers, technicians, and interns.
  • Collaborate and communicate with cross-functional teams and leadership.

  • 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.
  • Must be able to work in a fast paced, high energy, collaborative team that possesses a strong sense of urgency.
  • Ability to work independently with high competency and little guidance.
  • Solid foundation of mechanical engineering fundamentals and ability to perform detailed engineering analysis including tolerance analysis & FEA.
  • Must be a creative problem solver that can think outside of the box to develop novel solutions to complex problems.
  • 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.
  • Excellent interpersonal skills and ability to work collaboratively

  • BS in Mechanical Engineering, Plastics Engineering, Biomedical Engineering, or equivalent combination of education and experience
  • Advanced degree strongly preferred.


Meet Your Recruiter

Fran Hardy

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