NESC Staffing
http://www.nesc.com
http://www.nesc.com
true
ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:
REQUIREMENTS:
EDUCATION:
Principal Mechanical Engineer
Andover, MA 01810 US
Posted: 04/01/2023
2023-04-01
2023-05-01
Job Number: 32053
Job Description
ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:
- Lead development of next generation capital equipment for the 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 development of test fixtures and protocols.
- Develop drawings and release documentation in accordance with applicable standards and SOPs.
- Prepare documentation to support 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.
REQUIREMENTS:
- 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
EDUCATION:
- BS in Mechanical Engineering, Plastics Engineering, Biomedical Engineering, or equivalent combination of education and experience
- Advanced degree strongly preferred.