Product Engineer II

About the role

This role focuses on supporting a high-volume medical device manufacturing line by providing hands-on production support, troubleshooting mechanical, electrical, and software-related issues, and driving continuous process improvements.

Responsibilities

• Provide day-to-day production support for a high-volume medical device manufacturing line, ensuring stable and efficient operations.
• Troubleshoot mechanical, electrical, and software-related issues that arise during manufacturing, including diagnosing production problems and investigating yield issues.
• Support device testing activities by reviewing test results, addressing test failures, and refining test methods to improve reliability and throughput.
• Perform root cause analysis on manufacturing issues and implement corrective and preventive actions to resolve problems and prevent recurrence.
• Investigate and analyze customer returns, identify failure modes, and implement design or process improvements that enhance product performance and reliability.
• Ensure all manufacturing processes, documentation, and testing methods comply with FDA regulations, GMP standards, and internal quality system requirements.
• Identify opportunities for manufacturing process improvement to reduce waste, improve yield, and support cost optimization initiatives.
• Collaborate closely with operations, manufacturing, quality, and engineering teams to ensure successful production outcomes and smooth issue resolution.
• Leverage AI tools and data-driven approaches to support project execution, streamline workflows, and improve operational effectiveness.
• Support sustaining engineering activities by maintaining and improving existing products and processes in a regulated medical device environment.
• Participate in or support CAPA and quality system activities by providing technical input, data analysis, and documentation as needed.
• Contribute to continuous improvement initiatives and help drive a culture of quality, compliance, and operational excellence within the manufacturing environment.

Essential Skills

• Bachelor's degree in Mechanical Engineering or Electrical Engineering.
• 1–3 years of engineering experience in a relevant field.
• Ability to troubleshoot mechanical, electrical, and software-related issues in a production or manufacturing environment.
• Experience supporting products in manufacturing or production environments, preferably in high-volume operations.
• Understanding of Good Manufacturing Practices (GMP) and experience working in regulated industries.
• Experience working with medical devices and familiarity with FDA-compliant manufacturing processes.
• Demonstrated ability to perform root cause analysis and implement effective corrective actions.
• Strong skills in manufacturing engineering, including process troubleshooting and optimization.
• Ability to work 100% onsite in a manufacturing facility environment in Lafayette, CO.
• Effective cross-functional collaboration skills, working with operations, manufacturing, quality, and engineering teams.
• Strong written and verbal communication skills for documenting issues, solutions, and process changes.
• Comfort using or learning AI tools to support project execution and operational improvements.

Additional Skills & Qualifications

• Experience in sustaining engineering, including ongoing product and process improvement activities.
• Background in customer return investigations, including failure analysis and implementation of corrective measures.
• Exposure to CAPA (Corrective and Preventive Action) processes and quality systems in a regulated environment.
• Experience in medical device regulatory environments with adherence to FDA and GMP requirements.
• Demonstrated ability to identify and implement manufacturing process improvements that enhance yield, quality, and efficiency.
• Interest in working on a long-term assignment with the opportunity to take ownership of a specific product line.
• Desire to gain or expand experience in regulated medical device engineering and cross-functional project work.

Work Environment

This role is based 100% onsite in a manufacturing facility environment in Lafayette, CO, supporting a high-volume medical device production line. The position follows a standard 40-hour work week and involves frequent, hands-on interaction with production equipment, test systems, and manufacturing processes. The engineer works closely with operations, manufacturing, quality, and engineering teams in a highly collaborative, cross-functional setting. The environment is governed by medical device regulatory requirements, with strict adherence to GMP and quality procedures, structured documentation, and formal change control. The role offers long-term project stability and the opportunity to take ownership of a product line while gaining broad exposure to regulated medical device engineering and continuous improvement initiatives.

Job Type & Location

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

Pay And Benefits

The pay range for this position is $38.00 - $55.00/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) Workplace Type This is a fully onsite position in Lafayette,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 actalentaccommodation@actalentservices.com for other accommodation options.