Senior Design Assurance Engineer

Senior Design Assurance Engineer

Work Flexibility: Hybrid

What you will do :

• Working effectively with respective cross functional stakeholders in product sustenance and assessing health risk.
• Owing risk management and usability deliverables as per ISO 14971 and IEC 62366-1 respectively.
• Experience in risk management activities in product sustenance teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
• Driving Critical Quality Attribute (CQA) assessment due to changes in manufacturing process and risk assessment impact of the changes. 
• Good understanding of verification and validation activities with a rigor to drive design philosophy; data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues and manufacturing processes.    
• Participation in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
• Influential partnership with R&D to drive safety and performance during change. 
• Effective communication and previous experience in implementing compliance regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process. 
• Strong interpersonal skills & communications skills.

What you will need:

• Experience- 5 years - 7 years
• Minimum of 5+ years’ experience in risk management, testing and analysis ideally in a strongly regulated environment such as medical device, military or aerospace industry
• BE/BTech/ME/MTech in Bio Medical / Mechanical Engineering or related field from premier institutes

Travel Percentage: 10%

Experience Level

Senior Level