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Principal Mechanical Engineer - Capital Equipment

Andover, MA 01810

Posted: 08/21/2023 Employment Type: Direct Hire/Perm Job Category: Engineering Job Number: 578256 Is job remote?: No Country: United States

Job Description

  • Lead the development of next generation capital equipment and sub-systems for the OCS Heart, OCS Lung, and OCS Liver product lines.
  • Responsible for CAD design, building, and testing of new concepts and iterating through the design process.
  • Provide direction to junior engineers, technicians, external industrial design teams, and OEM manufacturers.
  • Demonstrate conformance to design requirements (reliability, performance, IEC 60601-1, etc.)
  • Procure materials and manage suppliers through the development process.
  • Develop drawings and release documentation in accordance with applicable standards and SOPs.
  • Assist V&V testing with protocols, reports, fixtures, and TMVs.
  • Maintain DHF including design reviews, test reports, meeting minutes, etc.
  • Perform other development tasks and duties as required.
  • 12+ years of product development experience as mechanical engineer with 6 years in a lead role for complex Class II or III medical capital equipment.
  • Expert in Solidworks 3D modeling and design. 3D surfacing expertise desired.
  • Expert in DFM of molded, machined, and sheet metal components.
  • Knowledgeable in plastic joining techniques including ultrasonic/RF/laser welding and adhesive/solvent bonding.
  • 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, GD&T, FEA, engineering 1st principles.
  • Must be a creative problem solver that can think outside of the box to develop novel solutions to complex problems.
  • 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, ISO 13485, IEC 60601-1 regulations and standards. 
  • Must be able to work in a fast paced, high energy, collaborative team that possesses a strong sense of urgency.
  • Prior project management experience and Six Sigma Green Belt desired.
  • Ability to be onsite a minimum of 4 days per week and lift 25lbs.
  • 20% Domestic or International travel may be required.
  • BS in Mechanical Engineering or equivalent is required.

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