Embedded Testing with Medical Device Domain

Embedded Testing with Medical Device Domain

Exp: 3Yrs

LOcaton: Bengalore

Key skills:

• Demonstrated knowledge of global quality and regulatory environment for medical devices including FDA CFR 21 part 820.30 and IEC(CE mark) ISO 13485 and risk management requirements and development dependencies.
• Solid understanding of medical device product development preferably Design Control experience with Class-III/Class-3 medical devices (FDA CFR Title 21 820.30).
• Solid understanding of System Verification and Validation test plan/protocols executing V&V activities generating and analysing test reports.
• Any programming language C C Python

Responsibility

• Supporting product verification through the phases of the Medical Device lifecycle.
• Providing technical support and leadership on a cross-functional team
• Define document and continuously improve verification tests including conducting peer reviews and maintaining traceability to requirements
• Perform verification tests and conduct analysis of the test results to ensure complete verification of the requirements
• Identifying analyzing and driving technical issues to resolution
• Perform work with little to no supervision as departments subject-matter expert
• Participates in design reviews including reviews of design verification plans reports and test artifacts.
• Development and execution of validation test plans test records and Test fixtures
• Keeps abreast of new developments in all relevant technological domains.
• Provides technical leadership to ensure overall product development success.
• Keeps abreast of new developments in all relevant technological domains.
• Contributes to technology roadmaps and other strategic activities
• Provides technical leadership to ensure overall product development success

Skillset and experienc

• Experience in the medical device or other similar industry
• Demonstrated knowledge of global quality and regulatory environment for medical devices including FDA CFR 21 part 820.30 and IEC(CE mark) ISO 13485 and risk management requirements and development dependencies.
• Solid understanding of medical device product development preferably Design Control experience with Class-III/Class-3 medical devices (FDA CFR Title 21 820.30)
• Experience specific to product verification.
• Solid understanding of System Verification and Validation test plan/protocols executing V&V activities generating and analyzing test reports
• Experience in designing and assessing compliance to national/international standards.
• Strong technical writing/documentation skills for a regulated medical device design environment including requirements definition
• Proven ability to communicate in both verbal and written form to technical and non-technical customers stakeholders and various levels of management.
• Possess strategic agility/vision: Sees ahead clearly; can anticipate future concerns.
• Develops and maintains effective relationships and is capable of quickly earning trust and respect.
• Ability to study and understanding of Schematics and PCBA
• Board bring up experience.
• Good Knowledge of EMI/EMC (IEC)artifacts and testing ISO 14971 (Risk Management) IEC 62304 (Software Lifecycle).
• Strong knowledge of embedded systems real-time operating systems (RTOS) and microcontroller-based architectures.
• Proficient in test development tools scripting languages (Python Shell etc.) and test automation frameworks.
• Experience with communication protocols (I2C SPI UART CAN BLE etc.).
• Experience with hardware-in-the-loop (HIL) and system simulation environments.
• Experience with version control systems (Git) and requirements management tools.