Manufacturing Engineer

Waterstone Human Capital; Salt Lake City (UT); On-site; USD 70,000 - 100,000; Full time

Job summary

Waterstone Human Capital's client, a medical device company, seeks a Manufacturing Engineer to drive process improvements and provide technical support across manufacturing and test ops in a regulated Class III environment.

You will work with R&D and Process Engineering to develop instructions, test methods, and equipment specs, ensuring quality, efficiency, and compliance while advancing heart valve manufacturing processes.

Qualifications

• BS in engineering with focus on mechanical/biomedical fields.
• Experience in regulated medical device industry or similar environment.
• Knowledge of 21 CFR 820 and ISO 13485 is a plus.

Responsibilities

• Develop and implement process improvements and tooling design.
• Provide engineering support for change analysis and manufacturing readiness.
• Conduct IQ/OQ/PQ activities for medical device production.
• Troubleshoot issues affecting safety, quality, cost, or delivery.
• Lead investigations and CAPAs using Lean/Six Sigma methodologies.
• Interface with R&D, production, suppliers to troubleshoot issues.
• Perform manufacturing processes related to polymer prep and device assembly.
• Train staff on equipment, procedures, and documentation.

Skills

Process improvement

Lean Six Sigma

Problem solving

Documentation practices

Cross-functional collaboration

Education

BS in Engineering

Tools

SolidWorks

3D CAD

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)