Product Transfer Engineer
Product Transfer Engineer
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Job Description
What will you do :
Collaborate with cross-functional teams (Engineering Quality Regulatory Supply Chain Manufacturing) to execute product transfers.
Responsible for process development and all process documentation (SOPs Work Instructions BOMs Routers PFMEAs Control Plans) is reviewed updated and transferred
Prepare and review PPAP documents (PFMEA Control Plans Process Flow Maps Process Capability Study inspection plans etc) and support method qualifications
Develop and qualify gages: perform Gage R&R and MSA studies
Review and qualify manufacturing processes ensuring regulatory and quality compliance
Coordinate with supplier quality and sourcing teams when components or suppliers are impacted.
Conduct equipment qualification process validation (IQ/OQ/PQ) and test method transfers
Perform technical reviews and gap analyses to assess receiving site readiness
Ensure compliance with regulatory quality and company standards during transfer activities
Support root cause analysis and troubleshooting during scale-up or post-transfer issues
Maintain detailed records of transfer activities and support audit readiness
What you will need :
Basic Qualification :
Bachelors degree in Engineering (Mechanical Electronics Mechatronics Electrical Industrial or equivalent).
2-6 years of experience in manufacturing process engineering or product transfers (preferably in medical device pharmaceutical or regulated industries).
Experience with process validation design control and quality systems (Preferred ISO 13485 FDA etc.).
Strong analytical organizational and communication skills.
Ability to work effectively across global cross-functional teams
Preferred Skills :
Familiarity with Lean Six Sigma or other process improvement methodologies is a plus.
Proficiency with tools such as Minitab SolidWorks SAP/ERP or PLM systems
Employment Type
Full-Time
