Roles & Responsibilities:
Bachelor’s or Master’s degree in Engineering or a related technical discipline (Mechanical / Electrical / Plastics / Manufacturing / Industrial Engineering)
Supporting NPI and Sustenance - Supporting product transfer, designing assembly procedures and handling manufacturing documentations.
Creating ECOs, Cos, Drawing updates, Fixture design and digital work instructions.
CAD requirement: Solidworks
Develop and execute validation protocols (IQ/OQ/PQ) for equipment, ensuring compliance with cGMP, FDA.
Strong experience in procurement engineering and supplier qualification
Collaborate with R&D, Quality, and Supply Chain teams to ensure successful product life cycle management and New Product Introduction (NPI).
Design exposure with ability to understand design intent, manufacturability, and tolerance implications
Strong ability to read and interpret engineering drawings (GD&T, materials, inspection requirements)
Drive continuous improvement to reduce waste, reduce costs, and improve yield using Lean Manufacturing and Six Sigma techniques.
Hands on experience with First Article (FA) planning, execution, and evaluation
Ability to perform fit, form, and function testing and validation
Experience completing and maintaining CQP and CQR documentation
Ability to work with multiple cross functional teams including Engineering, Sourcing, Operations, and SQEs
Experience working as an interface between suppliers and customer plant teams
Strong ownership mindset with ability to drive activities end to end to completion
Strong communication skills for supplier coordination and follow ups
Ability to track, report, and close issues within defined project timelines
Working knowledge of ASTM and equivalent international standards
Exposure to PPAP / APQP and customer quality procedures
Experience in Supplier Corrective & Preventive Action (CAPA) management
Ability to manage Product Deviation Notices (PDN) and drive closure with suppliers
Exposure to Supplier Process Audits and audit report documentation
Strong analytical c apability to track, report, and interpret supplier quality KPIs
Ability to escalate unresolved supplier quality issues within project timelines
Good-to-Have:
Experience in regulated manufacturing or life sciences industry
Exposure to procurement engineering and production buying operations
Familiarity with supplier contract terms and transition documentation
Experience supporting ERP transitions or system updates
Experience in alternate supplier identification and qualification
Exposure to automotive / industrial / manufacturing quality standards
Knowledge of APQP, PPAP documentation, and qualification reports
Familiarity with quality KPI dashboards and large scale data handling
Experience supporting new product development (NPD) projects