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 MANUFACTURING ENGINEER

Location: Salt Lake City, UT (On-site)

Reports to: VP Engineering & Operations

Compensation: $90,000 - $130,000

Company Overview

Our client is a medical device company developing innovative implantable cardiac technology. They operate in a regulated Class III environment and are led by a team with deep experience across device design, materials science, and commercial medical device development. The organization is at an exciting stage of growth, with a strong focus on advancing technology toward broader patient access.

Your Role:

The Manufacturing Engineer supports process improvements and provides technical support to manufacturing and test operations. Working closely with R&D and Process Engineering, you will develop and maintain process instructions, test methods, and equipment specifications while driving quality, efficiency, and compliance across a regulated Class III medical device production environment.

What You’ll Do:

·      Develop and implement process and product improvements, including tooling and fixture design using solid modelling tools

·      Support day-to-day manufacturing operations and provide engineering support for change analysis, risk analysis, and manufacturing readiness

·      Conduct qualification, verification, and validation activities (IQ/OQ/PQ) to support medical device production

·      Analyze, troubleshoot, and resolve issues relating to safety, efficacy, quality, cost, or delivery of components and finished devices

·      Lead failure investigations, non-conformances, and CAPAs; drive improvements using Lean and Six Sigma methodologies

·      Interface with R&D, production supervisors, suppliers, and vendors to troubleshoot issues and develop fixtures, components, and processes

·      Perform manufacturing processes relating to polymer preparation and heart valve manufacturing

·      Manage training for new and current employees on equipment, laboratory techniques, documentation, and department procedures

What You’ll Bring:

·      BS in Engineering (Mechanical, Biomedical, or related field)

·      2+ years of medical device experience or equivalent experience in a regulated industry

·      Knowledge of Class III medical device manufacturing and 21 CFR 820, ISO 13485, and related standards

·      Experience with SolidWorks or other 3D CAD software (required); ability to understand complex geometry and drawing requirements

·      Strong problem-solving, analytical, and critical thinking skills with good documentation practices

·      Good working knowledge of MS Office (Word, Excel, PowerPoint)

·      Experience with PLCs and motion control systems (a plus)