Job Summary
The Senior Designer plays a pivotal role in Hardware design and development of medical devices, capital systems and accessories that adhere to customer requirements. This role involves collaborating with various stakeholders to draft design specifications, developing innovative prototypes, POC’s, Design & Development, Testing, V&V and ensuring that designs integrate seamlessly within the broader project framework.
Key Responsibilities
- Draft System Requirements and Hardware functional requirements for Medical Device Systems, capital equipment and accessories.
- Develop and Validate Prototypes and Proof-of-Concept models for system, sub-system and critical components to support system characterization and make design decisions.
- Draft design documents, schematics, BOM Generation, PCB & Gerber Layout board design and review, coordinating with vendor and CM for manufacturing and release.
- Perform System and Sub-system Testing, Troubleshooting, V&V, drafting test protocols, test execution, and report generation.
- Coordinate With Cross-Functional Teams, including System, Software, Mechanical, team to ensure cohesive integration of design and release within overall Project.
- Mentor Junior Designers by sharing expertise in Hardware Design Methodologies through Training Sessions and Comprehensive Documentation.
- Work With Quality Assurance & Regulatory Teams To Define And Implement Quality Standards, Ensuring That All Designs Meet Established Performance And Reliability Benchmarks.
Skill Requirements
- Bachelors/Master’s degree in Electrical Engineering or other related technical degree.
- Minimum 4 years of NPD design & development life cycle experience preferably in medical device or in any research and development regulated industry.
- Proficient in Digital, Analog and mixed based design circuits and interface involving I2C, SPI, USB and PCI communication.
- Familiarity with Prototyping Tools, Techniques for Proof-of-Concept Implementations, reliability testing, FMEA.
- Knowledge in component engineering , critical component selection, obsolescence management and supply chain management using tools like HIS, Silicon Expert
- Knowledge in Testing, Troubleshooting, V&V, drafting test protocols, test execution, and report generation.
- Effective cross-functional collaboration and communication Skills.
Other Requirements
1. Knowledge in ISO 13485, IEC 60601 standards
