Softworld, Inc. MSP Fulfillment
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Principal Mechanical Engineer
Andover, MA
Salaried $160K-$180K
US Citizenship is Required
Principal Mechanical Engineer - Disposables
ESSENTIAL DUTIES INCLUDE:
BACKGROUND AND QUALIFICATIONS:
EDUCATION:
Principal Mechanical Engineer - Disposables
Posted: 01/22/2024
2024-01-22
2024-03-20
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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About Andover, MA
Discover exciting job opportunities around Andover, Massachusetts, with our expert staffing assistance! Nestled in the heart of the Bay State, Andover offers a blend of historic charm and modern amenities that make it an ideal place to grow your career. With proximity to Boston and the stunning beauty of Harold Parker State Forest nearby, Andover provides a perfect balance of urban convenience and natural retreats. Explore the area's rich history at the Addison Gallery of American Art, catch a show at the Andover Historical Society or enjoy a game cheering for the New England Patriots at Gillette Stadium. Embrace a vibrant community, delectable local cuisine, and endless opportunities for professional advancement. Begin your journey to success in Andover today!