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 :Bachelor’s 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
Travel Percentage: 10%