Mechanical Design Engineer

Finish Line Staffing Services; Attleboro (MA); On-site; USD 110,000 - 170,000; Full time

Job summary

Finish Line Staffing Services seeks an experienced Mechanical Design Engineer to lead development projects in the medical device space. You will apply SolidWorks to create robust components, manage design reviews, and drive design for automation initiatives.

The role requires 5+ years in design engineering, proficiency with FDA QSR and ISO 13485 design controls, and hands-on experience with injection molding, metal forming, welding, and related joining methods.

Qualifications

• 5+ years of experience in design engineering
• Demonstrated leadership in developing new products, technologies, and associated processes
• Experience in injection molding, metal forming, welding, and other metal and plastic joining methods
• Experience with design for automation
• Working knowledge of FDA Quality System Regulation (QSR) and ISO 13485 guidelines related to Design Controls

Education

Bachelor's Degree in Mechanical Engineering (B.S., M.E.)

MS Degree in Engineering

Tools

SolidWorks design software

Job description

Required Qualifications and Work Experience:

• Must be US Citizen or Green Card Holder
• Bachelor's Degree in Mechanical Engineering (B.S., M.E.)
• 5+ years of experience in design engineering
• Proficiency in SolidWorks design software
• Demonstrated leadership in developing new products, technologies, and associated processes
• Experience in injection molding, metal forming, welding, and other metal and plastic joining methods
• Experience with design for automation
• Working knowledge of FDA Quality System Regulation (QSR) and ISO 13485 guidelines related to Design Controls

Preferred Qualifications and Work Experience:

• M.S. Degree in Engineering
• 7 + years of medical device engineering experience
• 5+ years’ experience in FDA and ISO 13485 design and manufacturing environment
• Electro-mechanical instrumentation and robotics operations