Work Flexibility: Hybrid
What you will do:
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Working effectively with respective cross functional stakeholders in product sustenance and assessing health risk.
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Owing risk management and usability deliverables as per ISO 14971 and IEC 62366-1 respectively.
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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.
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Driving Critical Quality Attribute (CQA) assessment due to changes in manufacturing process and risk assessment impact of the changes.
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Good understanding of verification and validation activities with a rigor to drive design philosophy.
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Good understanding of data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
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Good understanding of manufacturing processes.
Required-
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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
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BE/BTech/ME/MTech in Bio Medical / Mechanical Engineering or related field from premier institutes
Preferred-
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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.
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Influential partnership with R&D to drive safety and performance during change.
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Effective communication and previous experience in implementing compliance regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process.
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Strong interpersonal skills & communications skills
Travel Percentage: 10%
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