Job Description Job Description
Hiring: Manufacturing Engineer
Location: Pleasanton, CA
Position: Manufacturing Engineer
Duration: Long-Term Contract
Industry: Medical Device
We are looking for an experienced Manufacturing Engineer with strong medical device manufacturing experience to support manufacturing process remediation, design transfer, and new product launch activities.
Key Responsibilities
Support manufacturing process remediation and readiness activities for new product launches.
Support Design Transfer deliverables, including tracking and scheduling.
Initiate and manage Change Orders for manufacturing documentation, procedures, shop-floor paperwork, and inspection procedures.
Perform Risk Management updates, including PFMEA.
Create and manage parts in Windchill, including BOM and configuration management.
Collaborate with cross-functional teams, including R&D, Quality, and Regulatory.
Ensure compliance with FDA regulations, ISO requirements, company policies, and quality procedures.
Support manufacturing process control and continuous improvement activities.
Required Qualifications
5+ years of Manufacturing Engineering experience in the medical device industry.
Strong experience with Design Transfer and New Product Introduction (NPI).
Hands-on experience with PFMEA / Risk Management.
Experience with Change Orders / Engineering Change Control.
Experience with Windchill, BOM, and configuration management.
Knowledge of FDA and/or ISO quality system regulations related to design transfer and process control.
Strong communication and cross-functional collaboration skills.
Preferred Qualifications
Previous medical device manufacturing experience.
Experience working with R&D, Quality, and Regulatory teams.
Knowledge of regulated manufacturing environments and quality systems.
Interested candidates? Please send your updated resume
