Principal Mechanical Engineer - Disposables
Andover, MA 01810 US
• 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.
• BS in Mechanical Engineering, Plastics Engineering, Biomedical Engineering, or equivalent is required.
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