Senior Medical Device Process Engineer | GMP & Lean Sigma

Actalent

Scottsdale (AZ)

On-site

USD 100,000 - 130,000

Full time

2 days ago

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Job summary

Actalent in Scottsdale, AZ is seeking a Senior Manufacturing Process Engineer to lead development, validation, and optimization of medical device manufacturing processes in a regulated environment. You will drive continuous improvement and support NPI with hands-on floor support and cross-functional collaboration.

The role requires 5+ years in IQ/OQ/PQ validations, ISO/FDA/GMP experience, and a strong background in CAPA, SPC, and Lean Six Sigma.

Qualifications

5+ years hands-on IQ/OQ/PQ validations in a regulated manufacturing environment.
5+ years experience with ISO standards, FDA 21 CFR Part 820, and GMP requirements.
Experience with CAPA, root cause analysis, SPC and continuous improvement initiatives.
Experience in medical device manufacturing or similarly regulated sector.
Knowledge of Lean Six Sigma in manufacturing.
Experience supporting New Product Introduction (NPI) and production transfers.

Responsibilities

Lead development, validation, and optimization of manufacturing processes for medical devices with focus on safety, quality and scalability.
Plan, execute, and document IQ/OQ/PQ validation activities.
Drive continuous improvement using Lean Six Sigma to enhance capability and throughput.
Support NPI and smooth transfer of processes into production.
Ensure compliance with ISO, FDA 21 CFR Part 820, and GMP requirements.
Lead CAPA activities with root cause analysis and sustainable fixes.
Use SPC and data-driven tools to monitor process performance.
Collaborate with cross-functional teams to resolve production issues.