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Principal Mechanical Engineer - Disposables

Andover, MA 01810

Posted: 08/21/2023 Employment Type: Direct Hire/Perm Job Category: Engineering Job Number: 578258 Is job remote?: No Country: United States

Job Description

ESSENTIAL TASK AND 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.
 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the recruiter to ensure it’s from @theplanetforward.com - and not a domain with an alternative extension like .net, .org or .jobs. Candidate safety is a top priority at Planet Forward.

Planet Forward and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.