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Sr Mechanical Engineer Product Development

  • Location: Andover, MA
  • Start Date: 2/2/2024
  • Job ID: 24-00074
  • Posting Date: 2/2/2024
  • Job Type: Direct Placement
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Sr Mechanical Engineer - Product Development

ESSENTIAL TASK AND DUTIES INCLUDE:

  • Lead the development of next generation disposables, durables, and accessories 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 engineers, technicians, external industrial design teams, and OEM manufacturers.
  • Work closely with manufacturing engineering and apply DFM techniques to ensure product is capable of being assembled and tested using automation.
  • Perform thorough analysis (tolerance, dFMEA, DOE, statistical) to ensure product will meet design requirements.
  • Manage injection mold suppliers through the tool development process and ensure conformance to specifications.
  • 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, reports, meeting minutes, etc.
  • Perform other development tasks and duties as required.

BACKGROUND AND QUALIFICATIONS:

  • 8+ years of product development experience as mechanical design engineer with 3 years in a lead role for complex Class II or III disposables and electromechanical medical equipment.
  • Expert in Solidworks 3D modeling and design. 3D surfacing expertise desired.
  • Experienced in design of injection molded disposables and plastic joining techniques including ultrasonic/RF/laser welding and adhesive/solvent bonding.
  • Some experience in design of electromechanical sub-systems including machined/sheet metal components and motorized assemblies.
  • Solid foundation of mechanical engineering fundamentals and ability to perform engineering analysis including tolerance analysis, GD&T, FEA, engineering 1st principles.
  • Ability to work independently with some guidance.
  • Must be a creative problem solver that can think outside of the box to develop Client solutions to complex problems.
  • Hands-on skills and ability to use power tools and light machine shop equipment required.
  • 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.
  • Project management experience & Six Sigma Green Belt desired.
  • Ability to be onsite 5 days per week and lift 25lbs.
  • 5% Domestic or International travel may be required.

EDUCATION:

  • BS in Mechanical Engineering, Plastics Engineering, Biomedical Engineering, or equivalent is required.
Posted by Brian Long
Technical Recruiting Manager
(800) 821-4644 x

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