Manufacturing Engineer

The Manufacturing Engineer will support the rapid scale-up of implantable medical device production in a highly regulated Class III environment. This role focuses heavily on equipment and process validation (IQ/OQ/PQ), continuous improvement, and sustaining manufacturing during a period of rapid growth. You will work hands-on with lasers, epoxy dispensing systems, robotics, and production cells to qualify new equipment, improve existing processes, and ensure robust, audit-ready manufacturing documentation.

Responsibilities

• Author and execute IQ/OQ/PQ equipment and process validations for lasers, epoxy dispensing systems, robotics, and duplicated production cells in a Class III medical device environment.
• Lead sustaining and continuous improvement initiatives to scale production and stabilize manufacturing during rapid growth.
• Support regulated medical device manufacturing in alignment with ISO and FDA expectations, including maintaining audit-ready documentation.
• Update and maintain design history file (DHF) and other quality system documentation as manufacturing processes evolve.
• Apply practical mechanical engineering judgment to design, refine, and maintain tooling, fixtures, and manufacturing processes, with a focus on manufacturability rather than pure product design.
• Develop and own validation protocols, test methods, and technical reports with minimal oversight, ensuring clarity, completeness, and regulatory compliance.
• Create and maintain manufacturing documentation, including work instructions, process documentation, and supporting records.
• Support and troubleshoot production equipment, processes, and production cells to maintain throughput, quality, and yield.
• Drive process improvements that enhance quality, performance, and efficiency across manufacturing operations.
• Collaborate closely with production, quality, and engineering teams to ensure smooth technology transfer and scalable manufacturing solutions.
• Contribute to risk management activities such as FMEA, and support statistical analysis of process data when applicable.
• Participate in internal and external audit activities by providing clear, complete validation and process documentation.

• Bachelor’s degree in Mechanical Engineering or a closely related field.
• 2–10 years of relevant engineering experience.
• Hands-on experience authoring and executing IQ/OQ/PQ validations for manufacturing equipment and processes.
• Manufacturing experience in a regulated or medical device environment.
• Experience supporting equipment, processes, or production cells, rather than working in purely design-only roles.
• Strong technical documentation and report-writing skills, including validation protocols, reports, and manufacturing documentation.
• Ability to apply mechanical engineering principles to tooling, fixtures, and manufacturing processes.
• Experience working within quality and regulatory expectations for medical device manufacturing.

• Experience with Class III or implantable medical devices.
• Hands-on experience with lasers, epoxy dispensing systems, robotics, or automated manufacturing equipment.
• Familiarity with ISO 13485:2016 (or similar ISO medical device standards) and FDA design controls.
• Experience duplicating, scaling, or transferring production lines and production cells.
• Exposure to FMEA, risk management methodologies, and basic statistical analysis of process data.
• Ability to work independently in a lean engineering team and take ownership of validation and improvement projects from start to finish.

This is an onsite role at a medical device manufacturing facility in Longmont, CO. The facility includes multiple cleanroom environments across several buildings, where you will work directly with modern production equipment such as lasers, epoxy dispensing systems, robotics, and automated cells. The team operates in a lean structure, and engineers are expected to problem-solve independently and take ownership of their projects. You will work on life-sustaining implantable medical devices with real patient impact in a clean, controlled manufacturing environment. The position offers a stable contract structure with paid time off and 11 paid holidays, and provides high visibility during a period of significant manufacturing growth, including the opportunity to own validation and process improvement initiatives from concept through implementation.

Job Type & Location

This is a Contract position based out of Longmont, CO.

The pay range for this position is $40.00 - $60.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Longmont,CO.

This position is anticipated to close on May 7, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $40 - $60