Senior Design Assurance Engineer

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: