Manufacturing Engineer

Stark Pharma Solutions Inc; Fremont (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

Stark Pharma Solutions Inc. in California is seeking a Manufacturing Engineer to develop manufacturing process flows for medical device product lines and to implement Training Within Industry (TWI) programs for operator training and standardized work.

You will create and maintain a process dictionary, support process mapping from pilot builds to full production, and collaborate across Manufacturing, Quality, R&D, and Operations to ensure compliance with FDA and ISO 13485 standards.

Qualifications

• Bachelor's degree in Mechanical Engineering.
• 5+ years of experience in medical device manufacturing or a regulated manufacturing environment.
• Hands-on experience developing and implementing TWI (Training Within Industry) programs.
• Experience creating and maintaining process dictionaries or standardized manufacturing documentation.
• Strong understanding of medical device manufacturing processes and regulatory requirements.
• Knowledge of FDA requirements and ISO 13485 standards.
• Strong communication, organizational, and cross-functional collaboration skills.

Responsibilities

• Develop, document, and maintain manufacturing process flows for medical device product lines.
• Develop and deploy TWI (Training Within Industry) training materials for operator training and standard work.
• Create and maintain a process dictionary to standardize manufacturing terminology, processes, and training content.
• Support process mapping and optimization from pilot builds through full production.
• Collaborate with Manufacturing, Quality, R&D, and Operations teams to ensure process compliance.
• Ensure manufacturing processes, documentation, and training materials align with FDA and ISO 13485 requirements.
• Support continuous improvement initiatives focused on efficiency, quality, and process repeatability.
• Provide support for process validation activities as needed.

Skills

TWI programs

Process documentation

Regulatory knowledge

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.

Position

Manufacturing Engineer

Location

California

Duration

Long Term

Job Overview

We are seeking a Manufacturing Engineer with strong mechanical engineering, manufacturing, and training experience to support process development, standardization, and workforce training within a regulated medical device manufacturing environment. The role will focus on developing manufacturing process flows, implementing TWI (Training Within Industry) programs, and maintaining standardized process documentation.

Key Responsibilities

• Develop, document, and maintain manufacturing process flows for medical device product lines.
• Develop and deploy TWI (Training Within Industry) training materials for operator training and standard work.
• Create and maintain a process dictionary to standardize manufacturing terminology, processes, and training content.
• Support process mapping and optimization from pilot builds through full production.
• Collaborate with Manufacturing, Quality, R&D, and Operations teams to ensure process compliance.
• Ensure manufacturing processes, documentation, and training materials align with FDA and ISO 13485 requirements.
• Support continuous improvement initiatives focused on efficiency, quality, and process repeatability.
• Provide support for process validation activities as needed.

Required Qualifications

• Bachelor s degree in Mechanical Engineering.
• 5+ years of experience in medical device manufacturing or a regulated manufacturing environment.
• Hands-on experience developing and implementing TWI (Training Within Industry) programs.
• Strong experience creating process flows, work instructions, standard work, and training documentation.
• Experience creating and maintaining process dictionaries or standardized manufacturing documentation.
• Strong understanding of medical device manufacturing processes and regulatory requirements.
• Knowledge of FDA requirements and ISO 13485 standards.
• Strong communication, organizational, and cross-functional collaboration skills.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.