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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 Country: United States Is job remote?: No

Job Description

ESSENTIAL TASK AND DUTIES INCLUDE: 
  • 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.
BACKGROUND AND QUALIFICATIONS:
  • 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.
EDUCATION:
  • BS in Mechanical Engineering or equivalent is required.

 

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The Planet Group and our companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Andover, MA

Discover exciting job opportunities around Andover, Massachusetts, with our expert staffing assistance! Nestled in the heart of the Bay State, Andover offers a blend of historic charm and modern amenities that make it an ideal place to grow your career. With proximity to Boston and the stunning beauty of Harold Parker State Forest nearby, Andover provides a perfect balance of urban convenience and natural retreats. Explore the area's rich history at the Addison Gallery of American Art, catch a show at the Andover Historical Society or enjoy a game cheering for the New England Patriots at Gillette Stadium. Embrace a vibrant community, delectable local cuisine, and endless opportunities for professional advancement. Begin your journey to success in Andover today!
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