Principal Mechanical Engineer - Disposables

Andover, MA 01810

Posted: 01/22/2024 Employment Type: Perm Industry: Engineering Job Number: BBBH73738_1705949745 Pay Rate: Up to US$175000.00 per year

Job Description


Principal Mechanical Engineer
Andover, MA
Salaried $160K-$180K
US Citizenship is Required

Principal Mechanical Engineer - Disposables

ESSENTIAL DUTIES INCLUDE:
  • Lead the development of next generation disposable systems 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:
  • 12+ years of product development experience as mechanical design engineer with 6 years in a lead role for complex Class II or III disposable medical equipment.
  • Expert in Solidworks 3D modeling and design. 3D surfacing expertise desired.
  • Expert in injection molding of biocompatible medical materials.
  • 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 & Six Sigma Green Belt highly 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, Plastics Engineering, Biomedical Engineering, or equivalent is required.
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