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Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
What you will do:
As a Senior Quality Engineer, Design Assurance you will lead risk management processes and design control activities for product sustenance. Being a part of this team means that you are working cross functionally to drive our company’s mission and strengthen the Stryker brand. You should love solving novel problems in fast paced and stimulating environment.
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.
Good understanding of data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
Good understanding of 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 need:
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