APPLY HERE
Location: Pune
Company: Philips
You Have The Opportunity To
- Enrich global experience within medical domain and build expertise in medical device electronics engineering
- Invasive and Non-Invasive Class II/III medical device electronics hardware Design History Files (DHFs) remediation
- Design, develop and maintain electronics engineering aspects for sleep and respiratory care products like Hospital/Home Ventilators
- Identifying appropriate technologies solutions for overall system, sub-system and component levels.
- Ensure solutions are consistent with the higher-level architecture and requirements and complies with Global Regulatory and Safety requirements.
- Play electronics engineering subject matter expert role in the development of new concepts for ventilator products and systems
- Manage EOL/Obsolescence issue in proactive manner
You Are Responsible For
- Responsible for electronics engineering deliverables which includes defining strategy and planning, design analysis, creating new or revising existing DHFs, reviewing and releasing DHFs
- Responsible for development and sustenance of embedded systems, controllers & processors, digital and analog circuitry, power supplies, connectivity interfaces.
- Develop and document designs in compliance with Quality Management System requirements.
- Authoring and reviewing design documentation including requirements specification, design docs, engineering analysis, schematic capture, test plans, test procedures, test records
- Design and development of new circuitry to replace aging/obsolete parts
- Develop new platforms, Integrate new technology, simplify designs, improve reliability to improve performance of sophisticated respiratory care medical equipment
- Create robust, reliable electrical board/system designs for critical care medical (respiratory care) equipment with complex electromechanical, electro-pneumatic, user interface, patient-response control, fault tolerance and regulatory requirements
- Support the assurance of supply of our products by resolving component obsolescence issues.
- Drive the quality and performance of products by identifying opportunities for improvement from field, supplier and manufacturing data.
- Support the manufacturing engineering team in troubleshooting and resolving issues discovered during production.
- Work with Design for Excellence (DfX) mindset to plan and execute Design for Manufacturability (DFM), Design for Testability (DfT) and Design for Serviceability (DfS).
Skills And Experience
- M.Tech /B.E/B.Tech Electronics Engineering from a reputed institute
- 6+ years of relevant experience in electromechanical devices, electronics, hardware design, development, and maintenance. Nice to have medical devices engineering experience
- End-to-end electronics hardware design & development, implementation, testing and documentation for electromechanical products
- Hands-on experience with embedded systems, controllers & processors, digital and analog circuitry, power supplies, connectivity interfaces.
- Expertise in design documentation, including requirements specification, design docs, engineering analysis, schematic capture, test plans, test procedures, and test records
- Well-versed with New Product Introduction (stage gate process) & Life Cycle Sustenance of medical products
- Exposure to Risk assessment tools & DFMEAs
- Hands-on experience in medical device documentation: DHF, DMR, BOM and Spec release
- Exposure to Modeling tools PSPICE, HyperLynx
- Exposure to International Quality and Regulatory Standards e.g. IEC, FDA, CFR, MDD, UL, CE, CSA, BIS
- Experience in IEC 61010-1, IEC 60601-1, IEC 60950-1 and IEC 62368-1 Safety standards.
- Experience in IEC EN 61326, FCC 15 EMC Standards
- Fluent in verbal and written English, proactive, can-do attitude, team player, decisive and entrepreneurial attitude
- Display perseverance & agility with an execution excellence mindset
