Posted:
4/10/2025, 9:12:53 PM
Location(s):
Gurugram, Haryana, India ⋅ Haryana, India
Experience Level(s):
Senior
Field(s):
Mechanical Engineering
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
Website: https://www.stryker.com/
Headquarter Location: Kalamazoo, Michigan, United States
Employee Count: 10001+
Year Founded: 1941
IPO Status: Public
Industries: Biotechnology ⋅ Health Care ⋅ Life Science ⋅ Medical ⋅ Medical Device