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Quality Engineer, Senior, Design & Reliability Assurance

The Senior Design Assurance Engineer will be responsible for supporting New Product Development (NPD), Sustaining Engineering and Continuous Improvement projects of varying scope and complexity. This individual will interact with internal and external design and development partners, participating on cross-functional project team through all phases of the product development process, and assisting technical teams with planning, executing, reporting and communicating Design Assurance work products and deliverables.

• Lead design and development of NPD projects, continuous improvement projects improved in close collaboration with Product Development, Project Management, RA, Marketing and Medical Affairs.

• Represent the Design Assurance function at Design Reviews, Technical Reviews, and Gate Reviews.

• Lead the execution of all Risk Management process activities, including design, process and application FMEAs per ISO 14971 (2019)

• Lead Continuous Improvement Projects in process, practice, procedures and tools to deliver measurable efficiency and productivity to the organization.

• Support external partners in the development projects, including establishment of Design Assurance deliverables, KPI’s, governance and reporting. Responsible for review and approval of Design Inputs and Outputs such as product requirements, system architectures, schematics, verification and validation plans/protocols/data/reports.

• Lead Design Transfer activities for complex NPD projects in collaboration with cross functional stakeholders including R&D, Supply Chain Operations, Manufacturing, Procurement and Operations Quality.

• Responsible to establish Design Assurance requirements and deliverables with external partners for NPD projects.

• Lead and coordinate, review and approve development documentation created by external partners, including product requirements, schematics, code, verification and validation test strategy, protocols and reports.

• Develop Reliability models for predicting and validating product performance over time.

• Application of statistical analysis to support data-driven decision making.

• Lead development of Design of Experiments (DOE) and statistically sound tests for appropriate support of results.

• Develop statistically based sampling plans for Design Verification and Validation or other studies as deemed necessary.

• Participate in FDA inspections, ISO Certification and surveillance audits and customer audits as an NPD subject matter expert.

• Writing & coordinating efforts for the development and implementation of new and updated Design Control processes, procedures and practices.

• Lead projects to ensure all are compliant with GMP, QSR, ISO or other applicable requirements.

• Identify and implement opportunities for continuous improvement in the quality system.

• Interact and coordinate activities with other departments, external vendors and customers.

• Perform other Quality Systems related duties as required.

• Bachelor’s Degree in Engineering (Mechanical, Systems, Chemical or Electrical) or Science (Biology, Chemistry) with 8 years of industrial experience

• Master’s Degree in Engineering (Mechanical, Systems, Chemical or Electrical) or Science (Biology, Chemistry) with 5 years of industrial experience

• Core knowledge of DFSS techniques with demonstrable capabilities in the areas of Design Optimization, Test Optimization, Systems Integration and Set Based Design.

• 4 to 6 years of experience in a Design Quality Assurance role for medical device or pharmaceutical product development

• Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making

• Demonstrates excellent organizational, verbal and written communication skills

• Proficient with the MS Office Suite, and statistical software tools

• Must be able to work independently with minimal supervision.

• Able to prioritize projects and manage assigned Design Assurance resources to meet organizational goals and objectives

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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