Manufacturing Engineer

MANUFACTURING ENGINEER

Medical Device | Salt Lake City, UT | Full-Time | On-Site

This role is responsible for leading the improvement of production methods and driving operational results within a medical device manufacturing environment. The engineer will work across manufacturing, quality, and product engineering to develop and refine processes, solve production problems, and build documentation that supports regulatory compliance.

The team is hands-on — engineers here build, test, document, and solve. The role is open to candidates at multiple experience levels; compensation is calibrated to depth of knowledge and fit.

KEY RESPONSIBILITIES

• Process Development: Collaborate on the design and improvement of manufacturing processes and procedures to increase efficiency and quality.
• Fixtures and Work Holding: Develop and implement fixture and work holding solutions that improve manufacturing operations.
• Documentation and Data: Build and maintain documentation that demonstrates process efficacy. Develop tests, collect data, and record findings to support compliance and continuous improvement.
• Work Instructions: Partner with operators to write and update standardized manufacturing work instructions that support consistent, quality output.
• Problem Solving: Identify root causes of production issues quickly and implement corrective actions to keep operations on track.
• Continuous Improvement: Contribute to a culture of ongoing improvement by identifying and implementing efficiency gains across the operation.
• Lean Principles: Apply lean methodologies to reduce waste and increase productivity throughout the production environment.

QUALIFICATIONS

• Bachelor's degree in mechanical engineering, manufacturing engineering, industrial engineering, or materials science. A master's degree is a plus.
• Familiarity with medical device regulations including 21 CFR Part 820 and ISO 13485. Direct experience is preferred.
• Knowledge of plastics, injection molding, press-forming, and related manufacturing equipment and materials.
• Demonstrated analytical skills including root cause analysis (RCA), structured problem-solving, statistical analysis, Design of Experiments (DOE), and risk-based decision making.
• Strong communication and interpersonal skills with the ability to collaborate across cross-functional teams.
• Bilingual in English and Spanish is helpful.
• Lean or Six Sigma certification is a plus.
• Minimum 1 year of manufacturing engineering experience required.

WORK REQUIREMENTS

• Location: On-site, 5 days per week at the Salt Lake City, UT manufacturing facility. This role cannot be performed remotely.
• Schedule: Standard business hours, full-time.
• Physical Requirements: Light to occasional medium physical work. Ability to lift up to 25 lbs. Requires standing, walking, stooping, reaching, lifting, pushing, grasping, and repetitive motion.
• Visual Requirements: Close vision, color vision, depth perception, and ability to adjust focus.
• Work Environment: Office, clean room, and other controlled manufacturing environments.

BENEFITS

• Medical, dental, and vision insurance
• 401(k) with company matching
• Health savings account (HSA)
• Life insurance
• Flexible schedule
• Paid time off
• Retirement plan