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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:
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.
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
Health benefits include: Medical and prescription drug insurance, dental
insurance, vision insurance, critical illness
insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing
program and
tobacco cessation program.
Financial benefits include:Health Savings Account (HSA),
Flexible Spending Accounts (FSAs),
401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability
insurance.
Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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