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Principle Mechancial Engineer

Tewksbury, MA

Posted: 12/01/2023 Industry: Engineering and Technical Job Number: 16273

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.

Title: Principal Mechanical Engineer
Hiring Organization: Connexion Systems & Engineering

  • Duration:  PERM
  • Pay rate: $120-145k
  • Job Location: Tewksbury, MA
  • Job# 16273

 
 ESSENTIAL TASK AND DUTIES INCLUDE: 
  • Lead the development of next generation capital equipment and sub-systems for the medical Heart, Lung, and 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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