Mechanical Design Engineer for Medical Devices & Automation

Mount Kemble Search Group; Portsmouth (NH); On-site; USD 95,000 - 125,000; Full time

Job summary

Mount Kemble Search Group is seeking a hands-on Mechanical Design Engineer II to design medical devices and develop semi-automated fixtures and manufacturing equipment. You will ensure robust product and tooling design with strong emphasis on manufacturability.

The role requires 5–8 years in engineering, including 3+ years in medical devices, proficiency in SolidWorks, PDM/PLM, and experience with automation, controls, and design validation.

Qualifications

• Bachelor's degree in Mechanical Engineering or related discipline required.
• 5–8 years engineering experience, including at least 3 years in medical devices.
• Experience designing injection-molded plastic components and assemblies.
• Knowledge of FDA QSR (21 CFR Part 820), ISO 13485/14971, and design controls.
• Experience supporting IQ/OQ/PQ validation activities.
• Hands-on automation experience with sensors, actuators, motors, pneumatics, PLCs, and controls.
• Ability to create and troubleshoot electrical schematics and wiring diagrams.
• Strong GD&T, tolerance analysis, SPC, and statistical analysis skills.

Responsibilities

• Design and develop plastic components, assemblies, and mechanisms for medical devices.
• Apply DFM and DFA principles across product and tooling designs.
• Support design verification and validation activities, including test protocol development and reporting.
• Participate in risk management activities (FMEA, hazard analysis).
• Design and build semi-automated assembly fixtures, tooling, and manufacturing equipment.
• Develop electromechanical solutions using sensors, actuators, motors, pneumatics, and controls.
• Collaborate with Quality, Regulatory, Manufacturing, and Operations to support launches and improvements.
• Maintain compliance with FDA, ISO quality system requirements.

Skills

DFM

DFA

Automation

Electrical schematics

Troubleshooting

Communication

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

PDM/PLM

AutoCAD

Job description

Mount Kemble Search Group is seeking a hands-on Mechanical Design Engineer II to design medical devices and develop semi-automated fixtures and manufacturing equipment. You will ensure robust product and tooling design with strong emphasis on manufacturability.

The role requires 5–8 years in engineering, including 3+ years in medical devices, proficiency in SolidWorks, PDM/PLM, and experience with automation, controls, and design validation.