NPI Manufacturing Engineer

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.

Position : NPI Manufacturing Engineer



Location : California



Duration : Long Term

Job Overview




We are seeking an NPI Manufacturing Engineer with strong experience in manufacturing, process development, and electromechanical systems to support new product introduction and manufacturing activities within a regulated environment. The role will focus on process development, validation, troubleshooting, equipment qualification, and continuous improvement.

Key Responsibilities




Support new product introduction and transition of products from development to manufacturing.
Develop, characterize, and optimize manufacturing processes for electromechanical products.
Collaborate with Design, Quality, R&D, Manufacturing, and Operations teams.
Execute process validation activities including IQ, OQ, and PQ.
Support Test Method Validation and verification activities.
Conduct DOE, FMEA, risk assessments, and process characterization.
Perform root cause analysis and troubleshooting of manufacturing issues.
Interpret engineering drawings, schematics, and technical specifications.
Utilize electrical test equipment including multimeters and oscilloscopes.
Support equipment qualification and manufacturing test activities.
Apply SPC, Lean, Six Sigma, and continuous improvement methodologies.
Prepare and maintain manufacturing, process, and validation documentation.
Support product transfer, process improvement, and production readiness activities.

Required Qualifications




Bachelor's degree in Mechanical Engineering, Industrial Engineering, Electrical Engineering, Biomedical Engineering, Robotics, Mathematics, or a related technical field.
5+ years of experience in manufacturing engineering, process engineering, NPI, or product/process development.
Experience with electromechanical systems and manufacturing process development.
Hands-on experience with IQ/OQ/PQ and process validation.
Experience with Test Method Validation, DOE, and FMEA.
Strong troubleshooting and root cause analysis skills.
Ability to interpret engineering drawings and schematics.
Experience with multimeters, oscilloscopes, or similar electrical test equipment.
Strong communication and cross-functional collaboration skills.

How to Apply




Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.




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