Principal Mechanical Engineer-- Medical Device

Principal Mechanical Engineer - Disposables

Reports to:  Director of Mechanical Engineering
$120-140K

 Andover, MA

The department of Manufacturing Engineering focuses on manufacturing of  Medical Devices and systems in Andover Massachusetts.  The team works on developing, maintaining, and improving manufacturing processes to support our initiative to deliver the highest quality technology to save patients’ lives.  

ESSENTIAL TASK AND DUTIES INCLUDE: 

• Lead the development of next generation disposable systems and accessories for the Medical Device 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.