MedTech Mechanical Engineer – Test Equipment & Validation

Barrington James; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Barrington James is seeking a Mechanical Engineer for a cutting-edge medical device company in Boston, MA. This onsite role collaborates across hardware, quality, and manufacturing to deliver robust test equipment and fixtures for glaucoma/corneal therapies.

Ideal candidates have 5+ years in medical device mechanical design, strong DFx knowledge, and familiarity with FDA/ISO quality systems to ensure compliant, manufacturable solutions.

Qualifications

• BS or MS in Mechanical Engineering, Opto-Mechanical Engineering, Manufacturing Engineering, Mechatronics, or related area.
• 5+ years mechanical, equipment design engineering experience for medical devices.
• Strong knowledge of FDA regulations, ISO 13485, ISO 14971, and applicable quality system requirements.
• Design for manufacture and assembly (DFM/DFA).

Responsibilities

• Design, specify, prototype, document, procure, assemble, qualify, implement, and improve test equipment mechanical components and equipment.
• Work closely with engineering teams to understand mechanical requirements, develop robust, reliable test and calibration equipment.
• Documentation to include equipment specifications, validation protocols, assembly instructions, preventative maintenance, and calibration (PMC) and CAD drawings.
• Analyze, debug and root cause measurement accuracy, reliability, repeatability, and reproducibility of equipment issues.
• Project manage equipment development projects coordinating with manufacturing and software teams.

Skills

Mechanical design

DFM/DFA

Project planning

Education

BS or MS in Mechanical Engineering

Job description

Barrington James is seeking a Mechanical Engineer for a cutting-edge medical device company in Boston, MA. This onsite role collaborates across hardware, quality, and manufacturing to deliver robust test equipment and fixtures for glaucoma/corneal therapies.

Ideal candidates have 5+ years in medical device mechanical design, strong DFx knowledge, and familiarity with FDA/ISO quality systems to ensure compliant, manufacturable solutions.