Working effectively with respective cross functional stakeholders in product sustenance and assessing health risk
Own Risk assessment deliverables and review associated design controls
Strong hold in verification and validation activities with a rigor to drive design philosophy
Data analysis and use statistical analysis to drive and make inform decisions.
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.
What you need-
Minimum of 6+ years’ experience in risk management, testing and analysis ideally in a strongly regulated environment such as medical device, military or aerospace industry
Preferably Bachelor’s Degree in Mechanical or Biomedical Engineering or equivalent
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.
Experience in the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.
Influential partnership with R&D to drive safety and performance during change
Previous experience in data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
Effective communication and previous experience in implementing compliance regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process.
Working experience in medical device industry is preferred.
Good knowledge with ISO 13485, ISO 14971, 21 CFR Part 820 standards
