Manufacturing Engineer, Medical Devices & Training Lead

Stark Pharma Solutions Inc; Santa Rosa (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

Stark Pharma Solutions Inc. seeks a Mechanical Engineer with strong manufacturing and training experience to support process development, standardization, and workforce training within a regulated medical device environment.

The role focuses on developing process flows, assembling and deploying TWI training programs, and creating a process dictionary to ensure consistent execution across the product line; you will collaborate with Manufacturing, Quality, R&D and Operations to meet FDA and ISO

Qualifications

• Bachelor's degree in Mechanical Engineering and 5+ years in a regulated environment.
• Hands-on experience developing and implementing TWI programs.
• Strong experience creating process flows, work instructions, and training documentation.
• Experience establishing and maintaining process dictionaries or standardized manufacturing documentation.
• Solid understanding of FDA and ISO 13485 requirements.

Responsibilities

• Develop, document, and maintain manufacturing process flows for medical device product lines.
• Assemble, customize, and deploy TWI training materials to support operator training and standard work.
• Create and maintain a process dictionary to standardize terminology, steps, and training content across manufacturing operations.
• Support process mapping and optimization across the full product lifecycle, from pilot builds through full production.
• Collaborate cross-functionally with Manufacturing, Quality, R&D, and Operations to ensure processes meet design and regulatory requirements.
• Ensure all processes, documentation, and training materials comply with FDA and ISO 13485 requirements.
• Support continuous improvement initiatives focused on efficiency, quality, and repeatability.
• Assist with process validation support as needed.

Skills

TWI programs

Process flows

Training documentation

Cross-functional collaboration

Education

Bachelor's degree in Mechanical Engineering

Job description

Stark Pharma Solutions Inc. seeks a Mechanical Engineer with strong manufacturing and training experience to support process development, standardization, and workforce training within a regulated medical device environment.

The role focuses on developing process flows, assembling and deploying TWI training programs, and creating a process dictionary to ensure consistent execution across the product line; you will collaborate with Manufacturing, Quality, R&D and Operations to meet FDA and ISO