Lead Mechanical Engineer, Medical Diagnostics

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

Benefits offered by this job

Medical and dental insurance

401k with company match

Generous vacation

9/80 work schedule

Paid holidays

Job summary

Actalent seeks an experienced Mechanical Engineer to design, develop, and optimize medical diagnostic devices from concept to commercialization. You will manage engineering drawings, specifications, and documentation in SolidWorks, while ensuring design controls and documentation meet regulatory standards.

You will apply electromechanical design principles, troubleshoot manufacturing issues, and contribute to FDA/ISO/EU MDR compliance.

Qualifications

• 8+ years of experience in medical device product development, focusing on mechanical and electromechanical systems.
• Advanced proficiency in SolidWorks for 3D modeling, assemblies, drawings, and design documentation.
• Strong mechanical design experience including design for manufacturability and reliability in medical devices.
• Hands-on experience with electromechanical design and integration with electronic/control systems.
• Experience troubleshooting manufacturing issues and leading root cause analyses.
• Experience working under FDA regulations, ISO standards, and EU MDR requirements for medical devices.
• Proficiency in production fixture design to support efficient, high-quality manufacturing.
• Knowledge of fabrication processes such as machining, molding, and assembly for medical devices.
• Experience working with biocompatible materials and medical-grade adhesives in device design.
• Strong technical writing skills to produce clear and compliant documentation.
• Excellent problem-solving and cross-functional collaboration abilities.

Responsibilities

• Design, develop, and refine medical diagnostic devices from concept through commercialization.
• Create, update, and maintain engineering drawings, specifications, and design documentation using SolidWorks and design control processes.
• Apply mechanical and electromechanical design principles to develop components, assemblies, and production fixtures.
• Troubleshoot manufacturing issues on the production floor and lead structured root cause investigations.
• Support product testing including verification and validation activities to meet performance and regulatory standards.
• Contribute to regulatory compliance efforts in line with FDA, ISO, and EU MDR requirements.
• Collaborate with production, quality, sales, marketing, and other cross-functional partners to meet clinical needs and manufacturing capabilities.
• Drive continuous improvement to improve performance, manufacturability, and cost reduction.
• Participate in design and development of electromechanical systems, including circuit integration and fabrication processes.
• Develop and refine production fixture designs to improve assembly efficiency and quality.
• Prepare clear technical documentation and design justifications for internal reviews and regulatory submissions.
• Communicate design decisions, risks, and recommendations to technical and non-technical stakeholders.

Skills

SolidWorks

Medical device design

Regulatory compliance

Electromechanical design

Root cause analysis

Cross-functional collaboration

Technical writing

Bachelor of Science in Mechanical Engg

Education

Bachelor of Science in Mechanical Engineering

Tools

SolidWorks

Job description

Actalent seeks an experienced Mechanical Engineer to design, develop, and optimize medical diagnostic devices from concept to commercialization. You will manage engineering drawings, specifications, and documentation in SolidWorks, while ensuring design controls and documentation meet regulatory standards.

You will apply electromechanical design principles, troubleshoot manufacturing issues, and contribute to FDA/ISO/EU MDR compliance.