5 Work Instructions Jobs

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.

Responsibilities: As a A Quality Management System (QMS) Engineer * Develop & maintain quality docs, including compliance with industry standards * Implement QMS,IATF, ISO standards, PPAP Process t audits. continuous improvement initiatives Provident fund Annual bonus Food allowance Health insurance Office cab/shuttle

Planing, execute & close quality system audits.Monitored effectiveness of previous audits & submit them 2 customer as per requirements.Control quality system documents like PFMEA,PQCT,Work Instructions(WI),Appearance Standards, Inspection Standards Required Candidate profile Organize meetings on company rules & regulations & amend/modify as needed.Lead training sessions on company's guidelines.Maintained change & revision history of documented quality system information

Role & responsibilities : Bachelors degree in aerospace or mechanical engineering 3 to 8 years of working experience with ME activities in aerospace programs Hands on experience in creating Work Instructions /Work Plans/Process Plans with thorough understanding of Aircraft Components/Assemblies build sequence using DELMIA DM tool on the 3DExperience platform Comprehensive understanding of Engineering Drawings, EBOM & MBOM, Task List, Build/Routing Sequence, Process Flow and Producibility checks Experience with DWS (Detail Work Statement) creation, business case preparation and process planning standardization Very good working experience in DELMIA DM tool 3DX platform and CATIA V5 tool experience Any automation experience in authoring/review of ME Planning content would be a plus Good communication skills to interact with all stakeholders (Engineering, Tooling, Production, Quality) to assure the requirement is completed correctly and delivered per schedule to the customer Preferred candidate profile: Must have DELMIA DM, 3DX Platform & CATIA V5, Manufacturing Engineering, Work Instructions, Aerospace Domain Tools: Catia V5, DELMIA DM, 3DX Platform

Your future role Take on a new challenge and apply your methodical and analytical expertise in a new cutting-edge field. You'll work alongside resourceful, innovative, and dedicated teammates. You'll contribute to the evolution of our products by bringing fresh ideas to the table, guiding product definition to improve manufacturability and achieve Quality, Cost, and Delivery (QCD) targets. Day-to-day, you'll work closely with teams across the business (Process Engineers, Product Introduction Managers), participate in product design reviews, and much more. You'll specifically take care of estimating Method Time, participating in P-FMEAs, and validating prototype designs, but also request and specify tooling as needed. We'll look to you for: Guiding product definition during specification and preliminary design phases Participating in product design reviews and P-FMEAs Estimating and calculating precise Method Time Writing tooling specifications and ensuring good EHS and ergonomic conditions Performing ERP routings, Work Instructions, Inspection Instructions, or CNC machine programming Validating product design and industrialization through FAR and FAI Industrializing retrofit after engineering changes post-serial Go Minimum Experience - 7 to 9 years Eductaion - Btech/ BE - Electrical, Mechanical, Electronics Autocad proficiency will be added advantage. Candidate muct be from production or manufacturing engineer background. If candidate has experience of Robot & PLC programing will be prefered.