Senior Design Assurance Engineer
Senior Design Assurance Engineer
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Job Description
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 623661 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.
Good understanding of data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
Good understanding of manufacturing processes.
Required
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
Preferred
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
Required Experience:
Senior IC
Employment Type
Full-Time
