Senior Medical Device Mechanical Engineer (Electromechanical)

Actalent; Highlands Ranch (CO); On-site; USD 120,000 - 140,000; Full time

Benefits offered by this job

Medical and dental insurance

Company paid life insurance

401k w/company match

Generous vacation

9/80 work schedule

Paid holidays

Job summary

Actalent is seeking a Mechanical Engineer to design, develop, and optimize medical diagnostic devices from concept through full commercialization, delivering robust, manufacturable solutions. You will create and maintain detailed engineering documentation, support testing and regulatory activities, and collaborate with cross‑functional teams to improve performance, manufacturability, and cost efficiency.

This onsite role is based in Highlands Ranch, CO, offering a challenging, hands‑on

Qualifications

• 8+ years of medical device product development, focusing on mechanical and electromechanical systems.
• Advanced proficiency in SolidWorks for 3D modeling, drawings, and design documentation.
• Strong design for manufacturability and reliability in medical devices.
• Hands-on electromechanical design integrating mechanical components with electronics and control systems.
• Experience with FDA regulations, ISO standards, and EU MDR for medical devices.
• Production fixture design to support efficient manufacturing.
• Knowledge of biocompatible materials and medical-grade adhesives.

Responsibilities

• Design, develop, and refine medical diagnostic devices from concept through commercialization.
• Create, update, and maintain engineering drawings, specs, and design docs using SolidWorks and design controls.
• Troubleshoot manufacturing issues and lead root cause investigations.
• Support verification and validation activities to ensure regulatory compliance.
• Contribute to regulatory submissions and alignment with FDA/ISO/EU MDR requirements.
• Collaborate with production, quality, sales, and marketing to meet clinical and manufacturability needs.

Skills

SolidWorks

Mechanical design

Electromechanical systems

FDA/ISO knowledge

Root cause analysis

Documentation

Cross-functional collaboration

Education

Bachelor of Science in Mechanical Engineering

Tools

SolidWorks CAD

Job description

Actalent is seeking a Mechanical Engineer to design, develop, and optimize medical diagnostic devices from concept through full commercialization, delivering robust, manufacturable solutions. You will create and maintain detailed engineering documentation, support testing and regulatory activities, and collaborate with cross‑functional teams to improve performance, manufacturability, and cost efficiency.

This onsite role is based in Highlands Ranch, CO, offering a challenging, hands‑on