Principal Mechanical Engineer
Lawrence, MA 01810 US
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Title: Principal Mechanical Engineer
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: PERM
- Pay rate: $150-160k
- Job Location: Lawrence, MA
- Job#: bh14364
Principal Mechanical Engineer
We are looking for an exceptional mechanical engineer with a proven track record of delivering innovative solutions to the disposable medical device market. This role is heavily focused on developing the next-generation disposables. A strong technical background and expertise in injection molding and SolidWorks are required. The ideal candidate will be extremely creative, and highly motivated and has brought complex medical disposables from concept to commercialization.
ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:
- Lead development of next-generation capital equipment for the OCS Heart, OCS Lung, and OCS Liver product lines.
- Work with external industrial design teams and OEM manufacturers to develop electromechanical sub-systems.
- Responsible for designing, building, and testing new concepts and iterating through the design process.
- Demonstrate subsystem reliability including the development of test fixtures and protocols.
- Develop drawings and release documentation by applicable standards and SOPs.
- Prepare documentation to support the quality system for design functions (project plans, design input, risk assessment, test protocols and reports, drawing specifications, etc.)
- Create development strategies and provide direction to junior engineers, technicians, and interns.
- Collaborate and communicate with cross-functional teams and leadership.
- 8+ years of product development experience as mechanical engineer with 4 years in a lead role for complex Class II or III medical capital equipment.
- Expert in Solidworks 3D modeling and design of injection-molded, machined, and sheet metal components.
- Must be able to work in a fast-paced, high-energy, collaborative team that possesses a strong sense of urgency.
- 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 & FEA.
- Must be a creative problem solver that can think outside of the box to develop novel solutions to complex problems.
- Knowledgeable in plastic joining techniques including ultrasonic/RF/laser welding and adhesive/solvent bonding.
- 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 and ISO 13485 regulations.
- Previous experience with IEC 60601-1 mechanical design requirements is strongly preferred.
- Prior project management experience and Six Sigma Green Belt desired.
- Excellent interpersonal skills and ability to work collaboratively
- BS in Mechanical Engineering, Plastics Engineering, Biomedical Engineering, or equivalent combination of education and experience
- Advanced degree strongly preferred.
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