Manufacturing Engineer

Job Title: Manufacturing Engineer

Location: Santa Rosa, CA (Onsite)

Seeking a Manufacturing Engineer to support process development, standardization, and workforce training in a regulated medical device manufacturing environment. The role focuses on process flow development, operator training using TWI principles, and standardized documentation to ensure consistent and compliant manufacturing execution.

• Bachelor’s degree in Mechanical Engineering
• 3+ years of experience in medical device manufacturing or regulated environment
• Hands‑on experience with TWI (Training Within Industry) or structured operator training
• Strong experience developing manufacturing process flows and work instructions
• Experience with standardized manufacturing documentation and process dictionaries
• Knowledge of FDA regulations and ISO 13485

• Develop and maintain detailed manufacturing process flows across product lines
• Create, customize, and deploy TWI-based training and standard work for operators
• Build and maintain a process dictionary to standardize terminology and execution
• Support process mapping from pilot builds through full‑scale production
• Collaborate with Manufacturing, Quality, R&D, and Operations teams
• Ensure compliance with FDA and ISO 13485 requirements
• Support continuous improvement and process validation activities

• Mid‑Senior level

• Contract

• Medical Equipment Manufacturing