Mechanical Engineer / NPI Engineer

Stark Pharma Solutions Inc; Santa Rosa (CA); On-site; USD 90,000 - 110,000; Full time

Job summary

Stark Pharma Solutions Inc in Santa Rosa, CA is seeking a Mechanical Engineer with manufacturing and training experience to support process development, standardization, and workforce training within a regulated medical device environment.

You will develop process flows, deploy TWI programs, and maintain a process dictionary to ensure consistent execution across the product line, while meeting FDA and ISO 13485 requirements.

Qualifications

• Bachelor's degree in Mechanical Engineering.
• 3+ years in medical device manufacturing or regulated environment.
• Hands-on experience developing and implementing TWI training.
• Experience creating process flows, work instructions, and training documents.
• Experience maintaining process dictionaries or standardized manufacturing documentation.
• Solid understanding of medical device manufacturing processes and regulatory expectations.

Responsibilities

• Develop, document, and maintain detailed 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 teams 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 training

Process flows

Documentation

Regulatory compliance

Cross-functional teamwork

Manufacturing engineering

Education

Bachelor's degree in Mechanical Engineering

Job description

Location: Santa Rosa, CA
Duration: Through end of year, with possible extension
Start Date: ASAP (September 1, 2026)

Position Summary

We are seeking a Mechanical Engineer with strong manufacturing and training experience to support process development, standardization, and workforce training within a regulated medical device environment. This role will focus on developing process flows, assembling and deploying TWI (Training Within Industry) programs, and creating a process dictionary to support consistent execution across the product line.

Key Responsibilities

• Develop, document, and maintain detailed manufacturing process flows for medical device product lines
• Assemble, customize, and deploy TWI (Training Within Industry) 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 teams 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

Qualifications

• Bachelor's degree in Mechanical Engineering
• 3+ years of experience in a medical device manufacturing or regulated environment
• Hands-on experience developing and implementing TWI (Training Within Industry) training
• Strong experience creating process flows, work instructions, and training documentation
• Experience establishing and maintaining process dictionaries or standardized manufacturing documentation
• Solid understanding of medical device manufacturing processes and regulatory expectations