Manufacturing Engineer

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

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Manufacturing Engineer

Role

Seeking 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 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 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.

Required

• Bachelor's degree in Mechanical Engineering.


• 5+ years of experience in medical device manufacturing or a regulated environment.


• Hands-on experience developing and implementing TWI (Training Within Industry) programs.


• 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 (FDA, ISO 13485).