Job Description

Work Flexibility: HybridResponsibilities and duties

• Conduct Risk Management per ISO14971 to ensure the safety and effectiveness of product.
• Conduct design reviews & risk management reviews as required during various project phases.
• Work with R&D during Electrical/ Embedded developments (Electrical & electronic hardware development and Software development) to provide inputs w.r.t quality & safety.
• Participate and conduct DHF / DMR Reviews for Software / Electrical/ Embedded developments.
• Support Computer System Validations & Process Validation as required.
• Support in conducting cybersecurity risk assessment documents.
• Support in V&V to ensure product compliance, safety, reliability & effectiveness.
• Review of Clinical Evaluation Reports, Post Market Clinical Follow up & Safety documentation and Regulatory documentation on Quality aspect.

• Practical implementation of Risk Management of Medical Device per ISO 14971.
• Experience with Risk Analysis tools and techniques.
• Experience on Medical Device Software Development Life Cycle Process (SDLC) IEC 62304.
• Experience on Medical Device Electrical/Electronic Hardware Development Life Cycle Process (HDLC).
• Understanding of various documentation required during Hardware & Software development lifecycle.
• Understanding of electrical & embedded components working principle and functionality.
• Familiarity with IEC 60601-1 family of standards.
• Familiarity with any basic programming language, embedded software & tools.
• Understanding of Quality Management Systems for Medical Devices. (ISO 13485, 21 CRF 820).

• B. Tech / B.E / M. Tech / M.S. - Software/ Electrical/ Embedded Engineering
• Experience: 4-8 years

Stryker