Senior Medical Device Automation Engineer

Waterstone Human Capital; Utah; On-site; USD 90,000 - 120,000; Full time

Job summary

Waterstone's client, a medical device company, seeks a Manufacturing Automation Engineer to design, build, and improve automated manufacturing equipment in a regulated Class III environment.

You will work with Manufacturing Engineering and outside integrators to develop process equipment, write specs, and drive quality and production efficiency on the factory floor. A BS in Engineering and 5+ years in automation are required.

Qualifications

• BS in Engineering (Mechanical, Electrical, or related field).
• 5+ years designing automated medical device manufacturing tooling and equipment, or equivalent in a regulated industry.
• Knowledge of PLCs, motion control systems, and robotic arms; IEC 61131-3 programming.
• Understanding of Class III medical device manufacturing and 21 CFR 820, ISO 13485, and related standards.
• Strong problem-solving and documentation practices.
• Experience with SolidWorks or similar CAD software.
• Proficient with MS Office (Word, Excel, PowerPoint).

Responsibilities

• Design and program automated manufacturing equipment from concept to end-of-life, including tooling.
• Collaborate with suppliers and integrators to develop process equipment; support daily manufacturing operations.
• Lead IQ/OQ/PQ validation activities for production.
• Troubleshoot production issues to optimize safety, quality, and efficiency; coordinate with R&D and production teams.
• Support change/risk analyses and manufacturing readiness; drive improvements with Lean and Six Sigma.

Skills

PLC programming

Motion control

Robotics

IEC 61131-3

Lean Six Sigma

Problem solving

Education

BS in Engineering (Mechanical, Electrical, or related field)

Tools

SolidWorks

3D CAD

MS Office

Job description

Waterstone's client, a medical device company, seeks a Manufacturing Automation Engineer to design, build, and improve automated manufacturing equipment in a regulated Class III environment.

You will work with Manufacturing Engineering and outside integrators to develop process equipment, write specs, and drive quality and production efficiency on the factory floor. A BS in Engineering and 5+ years in automation are required.