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

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

• 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.

• 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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