**Position summary**

Partner with Engineering and Advanced Operations to define design requirements and develop manufacturing processes to support new product development projects. Lead risk management activities to ensure the highest level of product and process quality.

**Key areas of responsibility**

+ Develop quality assurance documentation to support new product development process and regulatory submissions.

+ Lead quality system maintenance byidentifyingand correcting deficiencies in procedures and practices.

+ Partner with cross-functional project teams to lead product and/or process design and development activities.

+ Lead risk management activities for new product development projects.

+ Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership.

+ Present risks associated with the product use during Design Reviews and track the design...