Global Prostate Solutions Ltd
Website:
globalprostatesolutions.com
Job details:
Global Prostate Solutions | Full-Time | 4–5 Years Experience | Banglore
Key Responsibilities
- Take end-to-end ownership of medical device manufacturing, from design transfer through production and continuous improvement.
- Review and develop 3D CAD models, 2D engineering drawings, BOMs, specifications, tolerances and GD&T.
- Develop and optimise manufacturing, assembly, inspection and testing processes.
- Lead supplier identification, technical evaluation, development, qualification and ongoing performance improvement.
- Support sourcing and procurement of machined, moulded, fabricated and other medical-device components.
- Develop SOPs, Work Instructions, inspection procedures, process flows, fixtures, jigs and production aids.
- Troubleshoot manufacturing and assembly issues and drive root-cause analysis and corrective actions.
- Support product testing, design verification/validation, process validation and equipment qualification.
- Ensure compliance with medical-device quality and regulatory requirements, including ISO 13485 and ISO 14971.
- Drive continuous improvement in quality, yield, cycle time, cost, scrap and rework.
- Manage engineering changes, NCRs, CAPA and manufacturing documentation.
Qualifications & Experience
- B.E./B.Tech in Mechanical, Manufacturing, Production, Mechatronics Engineering or equivalent.
- 4–5 years of relevant experience in medical device manufacturing/engineering.
- Hands-on experience in mechanical product design, manufacturing and assembly.
- Experience with engineering drawings, tolerances and GD&T.
- Practical experience with CNC machining, fabrication, injection moulding and related manufacturing processes.
- Experience in supplier development, sourcing and procurement of engineering components.
- Working knowledge of ISO 13485 and medical-device manufacturing requirements.
- Experience with design transfer, manufacturing documentation and change-control processes.
- Experience with interventional, urology, radiology, biopsy or surgical medical devices is highly preferred.
Key Skills
- CAD: SolidWorks / AutoCAD / Creo or equivalent
- 3D modelling & 2D engineering drawings
- GD&T and tolerance stack-up
- Design for Manufacturing (DFM) & Design for Assembly (DFA)
- CNC machining – turning & milling
- Sheet-metal fabrication & injection moulding
- Prototyping / 3D printing
- Mechanical assembly and manufacturing process development
- Supplier development & supplier quality
- Inspection methods & process capability
- Root Cause Analysis, FMEA, CAPA & NCR management
- ISO 13485 & ISO 14971
- Design Controls, Design Transfer & Process Validation
- Strong problem-solving, troubleshooting and continuous-improvement skills
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