Medical Device Manufacturing Engineer II – Lean & NPI

Willow Laboratories, Inc.; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Collaborative workplace

Competitive compensation

Training opportunities

Patient health impact

Job summary

Willow Laboratories, Inc. in Irvine, CA is seeking a Manufacturing Engineer to help design, validate and optimize manufacturing processes for devices and consumables.

You will lead NPI and existing line improvements, applying Lean and Six Sigma to cut waste, reduce costs and improve quality. The role involves cross‑functional collaboration with R&D, Quality and Production, plus hands‑on process validation, equipment qualification and documentation in a regulated environment.

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Electrical, Manufacturing or related field.
• 3–6 years of manufacturing or process development experience in a regulated industry.
• Good understanding of GMP, FDA, or ISO 13485.
• Working knowledge of lean tools (5S, VSM, Poka-Yoke).
• Proficient with process validation and quality regs (IQ/OQ/PQ, CAPA).
• Experience with CAD SolidWorks and MS Office; statistical tools (Minitab/JMP).
• Strong communication, problem‑solving and documentation skills.

Responsibilities

• Develop and implement manufacturing processes for new and existing devices.
• Draft and maintain work instructions, validation docs in quality system.
• Lead small‑scale yield, efficiency, or cost‑reduction projects.
• Support daily production troubleshooting and process monitoring.
• Collect and analyze production data and report findings to stakeholders.
• Design and qualify equipment, tooling, and fixtures used in production.
• Perform IQ/OQ/PQ and develop Master Validation Plans and Reports.
• Apply Lean principles to reduce waste and improve workflow.
• Conduct statistical analyses (SPC, ANOVA, DOE) to improve processes.
• Carry out time studies, RCA, and capability studies for data‑driven decisions.
• Create and maintain pFMEA and assist risk mitigation strategies.
• Ensure FDA/ISO compliance and support design transfer and scale‑up.
• Train personnel on new or revised processes and participate in Kaizen events.

Skills

Lean Manufacturing

Six Sigma

Process Validation

SolidWorks

GMP/FDA knowledge

Data analysis

Documentation

Cross-functional collaboration

Education

B.S. in Mechanical Engineering

Tools

SolidWorks

Minitab

Excel

JMP

Job description

Willow Laboratories, Inc. in Irvine, CA is seeking a Manufacturing Engineer to help design, validate and optimize manufacturing processes for devices and consumables.

You will lead NPI and existing line improvements, applying Lean and Six Sigma to cut waste, reduce costs and improve quality. The role involves cross‑functional collaboration with R&D, Quality and Production, plus hands‑on process validation, equipment qualification and documentation in a regulated environment.