Principal Mechanical Engineer - Capital Equipment
Andover, MA 01810 US
- Lead the development of next generation capital equipment and sub-systems 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 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.