NPI Manufacturing Engineer

Stark Pharma Solutions Inc; San Jose (CA); Presencial; USD 110.000 - 160.000; Jornada completa

Descripción de la vacante

Stark Pharma Solutions Inc., a global consulting and staffing partner, seeks an NPI Manufacturing Engineer in California. This role focuses on process development, validation, troubleshooting, equipment qualification, and continuous improvement to support new product introduction and manufacturing readiness.

You will collaborate with Design, Quality, R&D, Manufacturing, and Operations to develop, validate and optimize electromechanical manufacturing processes, conduct DOE and FMEA, and ensure

Formación

• Bachelor's degree in Mechanical, Industrial, Electrical, Biomedical, Robotics, Mathematics or related 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 or oscilloscopes.

Responsabilidades

• 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.

Conocimientos

Strong troubleshooting

Cross-functional collaboration

DOE

FMEA

Process validation

Root-cause analysis

Interpret engineering drawings

Educación

Bachelor's degree in Mechanical Engineering or related field

Herramientas

Multimeters

Oscilloscopes

Descripción del empleo

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.

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.

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