Mechanical Design Engineer - Automation & Medical Devices

Mount Kemble Search Group; Portsmouth (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

Mount Kemble Search Group is seeking a hands-on Mechanical Design Engineer II to support design, development, verification, validation, and manufacturing integration of innovative medical devices. This role focuses on product design while also developing semi-automated assembly fixtures, tooling, and equipment to support production.

The ideal candidate will collaborate with Quality, Regulatory, and Operations teams, applying DFM/ DFA and contributing to risk management and design controls.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• 5–8 years of engineering experience, including 3+ years in the medical device industry.
• Experience designing injection-molded plastic components and assemblies.
• Knowledge of FDA QSR 21 CFR Part 820, ISO 13485, ISO 14971, and design controls.
• Experience supporting IQ/OQ/PQ validation activities.
• Proficiency with SolidWorks and PDM/PLM.
• Experience designing assembly fixtures, tooling, and semi-automated manufacturing equipment.
• Hands-on experience with automation systems (sensors, motors, actuators, pneumatics, PLCs).
• Ability to create and troubleshoot electrical schematics and wiring diagrams.

Responsibilities

• Design and develop plastic components, assemblies, and mechanisms for medical devices.
• Apply Design for Manufacturability (DFM) and Design for Assembly (DFA) principles.
• Support design verification and validation activities, including testing, protocol development, and reporting.
• Participate in risk management activities, including FMEA and hazard analysis.
• Design and build semi-automated assembly fixtures, tooling, and manufacturing equipment.
• Develop electromechanical solutions using sensors, actuators, motors, pneumatics, and controls.
• Create and interpret electrical schematics and wiring diagrams.
• Support IQ/OQ/PQ activities for manufacturing equipment and processes.
• Troubleshoot manufacturing equipment, fixtures, and automation systems.
• Collaborate with Quality, Regulatory, Manufacturing, and Operations teams to support product launches and continuous improvement initiatives.
• Maintain compliance with FDA, ISO, and applicable quality system requirements.

Skills

Mechanical design

Medical devices

Automation & assembly

SolidWorks

PDM/PLM

DFM/DFA

Electrical schematics

Automation systems

GD&T

Education

BS Mechanical Eng

Tools

PLC controls

Automation hardware

Job description

We are seeking a hands-on Mechanical Design Engineer II to support the design, development, verification, validation, and manufacturing integration of innovative medical devices. This role will focus on product design while also playing a key role in developing semi-automated assembly fixtures, tooling, and manufacturing equipment to support production and process improvements.

The ideal candidate will bring a strong background in mechanical design, medical device development, and automation, with the ability to design both products and the equipment used to manufacture them.

Key Responsibilities

• Design and develop plastic components, assemblies, and mechanisms for medical devices.
• Apply Design for Manufacturability (DFM) and Design for Assembly (DFA) principles.
• Support design verification and validation activities, including testing, protocol development, and reporting.
• Participate in risk management activities, including FMEA and hazard analysis.
• Design and build semi-automated assembly fixtures, tooling, and manufacturing equipment.
• Develop electromechanical solutions using sensors, actuators, motors, pneumatics, and controls.
• Create and interpret electrical schematics and wiring diagrams.
• Support IQ/OQ/PQ activities for manufacturing equipment and processes.
• Troubleshoot manufacturing equipment, fixtures, and automation systems.
• Collaborate with Quality, Regulatory, Manufacturing, and Operations teams to support product launches and continuous improvement initiatives.
• Maintain compliance with FDA, ISO, and applicable quality system requirements.

Required Qualifications

• Bachelor's degree in Mechanical Engineering or related discipline.
• 5-8 years of engineering experience, including at least 3 years in the medical device industry.
• Strong experience designing injection-molded plastic components and assemblies.
• Working knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, ISO 14971, and design controls.
• Experience supporting IQ/OQ/PQ validation activities.
• Proficiency with SolidWorks and PDM/PLM systems.
• Experience designing assembly fixtures, tooling, and semi-automated manufacturing equipment.
• Hands-on experience with automation systems, including sensors, motors, actuators, pneumatics, PLCs, and controls.
• Ability to create and troubleshoot electrical schematics and wiring diagrams.
• Experience troubleshooting manufacturing and automation equipment.
• Knowledge of GD&T, tolerance analysis, SPC, and statistical analysis tools.
• Strong problem-solving, communication, and teamwork skills.

Preferred Qualifications

• Experience with autoinjectors, pen injectors, wearable injectors, or other drug delivery devices.
• Experience with robotics, vision systems, and advanced automation technologies.
• Lean Manufacturing and/or Six Sigma experience.
• Knowledge of ISO 10993 and sterilization processes.
• Experience in combination products or regulated life science manufacturing environments.

Why Join?

This is an opportunity to work on innovative medical technologies while helping develop the manufacturing equipment and automation solutions used to bring products to market. The role offers a unique blend of product development, mechanical design, manufacturing engineering, and hands-on automation.