Us Citizen
Green Card
EAD (OPT/CPT/GC/H4)
H1B Work Permit
Corp-Corp
Consulting/Contract
UG :- - Not Required
PG :- - Not Required
No of position :- ( 1 )
Post :- 18th Sep 2021
o Hands on experience in design and development
o Hands on experience in FDA regulated Design Control, Change Control, NPD flow, VAVE.
o Good understanding of ISO 13485, 21 CFR Part 820 standards and risk management (ISO 14971)
o Design-related experience and knowledge of general design engineering and DFMA principles, component manufacturing processes, tooling methodologies, material properties, and regulatory compliance
o Experience in NPD of Plastic/Metal components
o Basic engineering (e.g., statistical techniques, validation protocol, process capability studies, process validation, developing solutions that meet quality, performance, and cost commitments).
o Experience with CAD/CAM and design analysis software with a basic knowledge and understanding of medical regulatory requirements
o Risk Management activities. Proven ability to perform root cause investigations, and CAPA process
o Writing technical documents is required
o Expected to lead the engineering change projects with minimal support from client SMEs
o Organizes and conducts Engineering builds
o Ability to understand and manage medical device manufacturing requirements for product or process change management
o Organize, plan, and execute change management plans for key Cost Saving initiatives
Support Develop, design, validation & start up manufacturing & assembly operations that meet:
o Team objectives for product quality, cost & performance
o Lead the qualification of:
· Assembly equipment/fixtures/processes
· Tooling-injection molding, stamping, machining, welding, assembly processes etc.
· Gage equipment—conduct MSA’s
o Support generation of all documentation & specifications for process & equipment including drawings, process specifications, PS & OM sheets, routers, IPQA specifications & troubleshooting guide
o Support the use of statistical techniques, develop validation protocols, qualify first articles, complete process capability studies & process validation on both internal & supplier processes