Senior Engineer, Design Assurance in Gurugram at Stryker Corporation

Date Posted: 10/1/2019

Job Snapshot

Job Description

Who we want:

  • Dedicated achievers : People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Persuasive influencers :  People who understand market positioning and can use their relationship skills and depth of knowledge to secure buy-in, cooperation, and loyalty.
  • Hard-working winners :  Confident, competitive and results-oriented who create a track record of success.
  • Collaborative partners : People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
  • Analytical problem solvers : People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

What you will do:

  • Working effectively with respective cross functional stakeholders in developing new product 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.

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
  • Preferably Bachelor’s Degree in Mechanical or Biomedical Engineering or equivalent
  • Experience in risk management activities for new product development 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.
  • 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 in new products   
  • 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. 

Work From Home: Yes

Travel Percentage: 0%

Join our talent network

Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Join Our Team