Design Assurance Engineer II

Act as an extended team member on a PDP Project, representing the Design Assurance function and reporting indirectly to the quality lead on the project. Prepare test method validations, design verification and shelf-life protocols/reports. Support and complete risk management documentation. Stay updated on industry best practices concerning product design. Keep expert knowledge of regulatory compliance requirements for product design, development, transfer, and commercialization activities. Collaborate with various departments to build strong partnerships. Provide Quality input into new product development, process improvements, and change control. Support cross-functional teams in designing protocols to ensure that new products or product changes are adequately evaluated and tested according to standard requirements. Prioritize timely presentation of quality issues and escalate to leadership based on sound engineering, analysis & review for the success of the business. Support internal and external audits.