Job
Description
The New Product Manufacturing Engineer (NPME) is responsible for ensuring smooth and compliant transition of new medical devices from design to manufacturing. This role plays a critical part in developing scalable, validated manufacturing processes, driving design for manufacturability (DFM), and executing Verification and Validation (V&V) activities in alignment with ISO 13485 and FDA 21 CFR Part 820. Key Responsibilities: Collaborate with R&D during the design phase to influence DFM and ensure manufacturability. Plan, execute, and document manufacturing Verification & Validation (V&V) activities, including equipment and process validations (IQ, OQ, PQ). Lead development of process documentation: PFMEA, control plans, work instructions, SOPs, and batch records. Develop manufacturing strategies, assembly procedures, and pilot line setups for new product introductions (NPIs). Drive tooling, fixture design, and automation planning for scalable and cost-effective production. Support and lead design transfer activities from engineering to manufacturing, ensuring production readiness. Participate in clinical builds and first article inspections (FAI), ensuring traceability and documentation compliance. Use statistical methods to analyse process capabilities and implement continuous improvements. Lead root cause investigations for manufacturing issues and support CAPA implementation. Collaborate cross-functionally with Quality, Regulatory, Supply Chain, and Production teams to ensure product launch timelines are met. Provide input and support for regulatory submissions related to manufacturing process and V&V outcomes. Qualifications: Bachelors degree in mechanical, Manufacturing, or Industrial Engineering. 5+years of experience in medical device manufacturing, new product introduction (NPI), and process development. Strong knowledge of Verification & Validation (V&V) principles and experience with IQ/OQ/PQ protocols. Familiarity with ISO 13485, GMP, and FDA 21 CFR Part 820. Proficiency with CAD (e.g., SolidWorks), ERP systems (e.g., Odoo, SAP), and statistical tools (e.g., Minitab, JMP). Demonstrated ability to write and review technical documentation for audits and regulatory submissions. Preferred Skills: Experience in Class II/III medical device product launches. Exposure to cleanroom practices and ESD-safe assembly. Hands-on experience in FMEA, and process optimization.
