On-Site Device Process Engineer - GMP Lean Six Sigma

ALKU; Salt Lake City (UT); On-site; USD 85,000 - 130,000; Full time

Job summary

ALKU, a leading provider of medical device manufacturing solutions, is seeking three on-site Process Engineers to support regulated manufacturing operations in Salt Lake City, Utah. Strong backgrounds in continuous improvement, GMP/GXP, and process qualification are required.

Candidates with heat treatment, electropolishing, or laser cutting experience will be prioritized. You will lead Lean and Six Sigma projects, perform IQ/OQ/PQ, apply DOE and FMEA, and maintain SOPs and change documents

Qualifications

• 3+ years of process engineering experience in a regulated manufacturing environment (medical device or pharma)
• Lean or Six Sigma certification with documented projects and results
• Hands-on IQ/OQ/PQ experience from protocol development through execution and reporting
• Knowledge of GMP/GXP requirements in a regulated environment
• Strong analytical skills with Gage R&R, DOE, and SPC

Responsibilities

• Lead process improvement projects using Lean and Six Sigma from problem identification to solution implementation and effectiveness verification
• Execute and support equipment and process qualifications including IQ/OQ/PQ protocols and reports
• Apply structured problem-solving tools (Gage R&R, DOE, FMEA, RCA) to resolve manufacturing issues
• Maintain GMP/GXP compliance and document activities per procedures
• Collaborate cross-functionally with quality, engineering, and operations to resolve manufacturing challenges
• Author and maintain SOPs, work instructions, and engineering change documentation
• Support characterization and process development activities across manufacturing operations

Skills

Lean Six Sigma

GMP/GXP experience

Problem-solving

Education

Engineering degree (Materials Science/Mechanical/Chemical)

Tools

IQ/OQ/PQ

Job description

ALKU, a leading provider of medical device manufacturing solutions, is seeking three on-site Process Engineers to support regulated manufacturing operations in Salt Lake City, Utah. Strong backgrounds in continuous improvement, GMP/GXP, and process qualification are required.

Candidates with heat treatment, electropolishing, or laser cutting experience will be prioritized. You will lead Lean and Six Sigma projects, perform IQ/OQ/PQ, apply DOE and FMEA, and maintain SOPs and change documents