Manufacturing Mechanical Engineer

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

Job Title: Mechanical Engineer

This role focuses on designing, developing, and improving medical diagnostic devices from initial concept through full commercialization. You will create and maintain detailed engineering documentation, support testing and regulatory activities, and collaborate closely with cross-functional teams to enhance product performance, manufacturability, and cost efficiency.

Job Description

This role focuses on designing, developing, and improving medical diagnostic devices from initial concept through full commercialization. You will create and maintain detailed engineering documentation, support testing and regulatory activities, and collaborate closely with cross-functional teams to enhance product performance, manufacturability, and cost efficiency.

Responsibilities

• Design, develop, and refine medical diagnostic devices from concept through commercialization, ensuring robust, reliable, and user-focused solutions.
• Create, update, and maintain engineering drawings, specifications, and design documentation using SolidWorks and established design control processes.
• Apply advanced mechanical and electromechanical design principles to develop components, assemblies, and production fixtures for medical devices.
• Troubleshoot manufacturing issues on the production floor and lead structured root cause investigations to resolve product and process problems.
• Support product testing, including verification and validation activities, to ensure devices meet performance requirements and regulatory standards.
• Contribute to regulatory compliance efforts by designing and documenting products in alignment with FDA regulations, ISO standards, and EU MDR requirements.
• Collaborate with production, quality, sales, marketing, and other cross-functional partners to ensure designs meet clinical needs, customer expectations, and manufacturing capabilities.
• Drive continuous improvement initiatives focused on product performance, manufacturability, and cost reduction, leveraging feedback from manufacturing and customers.
• Participate in the design and development of electromechanical systems, including circuit integration and fabrication processes, to support diagnostic device functionality.
• Develop and refine production fixture designs that improve assembly efficiency, quality, and consistency.
• Prepare clear, accurate technical documentation, reports, and design justifications to support internal reviews and regulatory submissions.
• Communicate design decisions, risks, and recommendations effectively to technical and non-technical stakeholders and contribute to cross-functional project planning.

Essential Skills

• Approximately 8+ years of experience in medical device product development, with a focus 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, including integration of mechanical components with electronic and control systems.
• Demonstrated ability to troubleshoot manufacturing issues and lead root cause analysis using structured problem-solving methods.
• Experience working under FDA regulations, ISO standards, and/or EU MDR requirements for medical devices.
• Proficiency in production fixture design to support efficient and high-quality manufacturing processes.
• Knowledge of fabrication processes relevant to medical device manufacturing, such as machining, molding, and assembly techniques.
• Experience working with biocompatible materials and medical-grade adhesives in device design and assembly.
• Strong technical writing skills with the ability to produce clear, complete, and compliant engineering documentation and reports.
• Excellent problem-solving skills with the ability to analyze complex issues and propose practical, data-driven solutions.
• Effective communication skills and proven ability to collaborate in cross-functional teams, including production, quality, sales, and marketing.
• Bachelor of Science degree in Mechanical Engineering or a related engineering discipline.

Additional Skills & Qualifications

• Experience supporting verification and validation testing of medical devices, including test method development and execution.
• Background in circuit design or working closely with electronics engineers to integrate mechanical and electronic components.
• Familiarity with continuous improvement methodologies aimed at enhancing product performance, manufacturability, and cost effectiveness.
• Comfort working in a global manufacturing environment and collaborating with teams across multiple locations.
• Strong attention to detail and commitment to quality in both design work and documentation.
• Ability to manage multiple projects and priorities in a fast-paced product development setting.

Work Environment

You will work as part of a small, highly collaborative engineering team in an onsite environment, five days per week. The organization operates global manufacturing facilities and a technical research and training center dedicated to healthcare solutions and clinical education. The work setting emphasizes hands-on engagement with production and testing, close interaction with cross-functional colleagues, and a culture focused on innovation in medical technologies, diagnostic and therapeutic procedures, continuing care, rehabilitation, and OEM device solutions.

Job Type & Location

This is a Permanent position based out of Highlands Ranch, CO.

Pay And Benefits

The pay range for this position is $120000.00 - $140000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

• Medical and dental insurance
• Company paid life insurance
• 401k w/company match
• Generous vacation
• 9/80 work schedule
• Paid holidays

Job Type & Location

This is a Permanent position based out of Highlands Ranch, CO.

Application Deadline

This position is anticipated to close on Oct 26, 2026.

Workplace Type

This is a fully onsite position in Highlands Ranch,CO.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.