Med Device Manufacturing Engineer — Lean Six Sigma

Planet Pharma; Irvine (CA); On-site; USD 73,000 - 88,000; Full time

Job summary

Planet Pharma, Irvine, CA, seeks a Senior Manufacturing Engineer to lead cost, quality, safety, and business continuity initiatives in a regulated medical device manufacturing environment.

The role requires strong expertise in equipment and process validation (IQ/OQ/PQ) and Lean Six Sigma-driven improvements, with cross-functional collaboration across Product Development, Quality, Operations, and Regulatory teams.

Qualifications

• Experience developing and executing IQ/OQ/PQ protocols.
• Understanding validation requirements in a regulated manufacturing environment.
• Proven ability to lead cross-functional projects from planning through implementation.

Responsibilities

• Lead cost, quality, safety, and business continuity initiatives in a medical device manufacturing environment.
• Drive process improvements with validation activities and Lean Six Sigma methodologies.
• Collaborate with Product Development, Quality, Operations, Supply Chain, and Regulatory teams to enable transfer and commercialization of products.

Skills

IQ/OQ/PQ protocols

Cross-functional project leadership

Lean Six Sigma in medical devices

Education

Bachelor's degree in Engineering

Advanced degree preferred

Job description

Planet Pharma, Irvine, CA, seeks a Senior Manufacturing Engineer to lead cost, quality, safety, and business continuity initiatives in a regulated medical device manufacturing environment.

The role requires strong expertise in equipment and process validation (IQ/OQ/PQ) and Lean Six Sigma-driven improvements, with cross-functional collaboration across Product Development, Quality, Operations, and Regulatory teams.