Manufacturing Engineer

Waterstone Human Capital; Salt Lake City (UT); On-site; USD 75,000 - 105,000; Full time

Job summary

Waterstone Human Capital is assisting a medical device company in Utah to hire a Manufacturing Engineer. You will support process improvements, develop and maintain process instructions, test methods, and equipment specifications in a Class III regulated environment.

You will work with R&D and Process Engineering to drive quality, efficiency, and compliance, perform IQ/OQ/PQ, and lead CAPAs and lean initiatives while supporting polymer and heart valve manufacturing processes.

Qualifications

• BS in Engineering (Mechanical, Biomedical, or related).
• 2+ years in medical devices or regulated industry.
• Knowledge of Class III manufacturing, 21 CFR 820, ISO 13485.
• SolidWorks or 3D CAD software (required).
• Strong problem-solving and documentation skills.
• MS Office (Word, Excel, PowerPoint).
• Experience with PLCs and motion control (a plus).

Responsibilities

• Develop and implement process and product improvements, tooling and fixture design.
• Support manufacturing operations and change analyses, risk analyses, and readiness.
• Conduct IQ/OQ/PQ activities for medical device production.
• Analyze and resolve issues affecting safety, quality, cost, or delivery.
• Lead CAPAs and drive Lean/Six Sigma improvements.
• Interface with R&D, production, suppliers to troubleshoot and develop fixtures.
• Handle polymer preparation and heart valve manufacturing processes.
• Train employees on equipment and procedures.

Skills

Analytical thinking

Documentation

Quality mindset

Teamwork

Education

BS in Engineering (Mechanical/Biomedical)

Tools

SolidWorks

PLCs

MS Office

Job description

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)