Staff Quality Engineer - Design Assurance - Oxenham Group LLC
Irvine, CA
About the Job
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.
Minimum required education and experience: Bachelor degree or equivalent with 8+ years of experience, Master degree with 5+ years of experience, Doctoral degree with 3+ years of experience
- 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.
Minimum required education and experience: Bachelor degree or equivalent with 8+ years of experience, Master degree with 5+ years of experience, Doctoral degree with 3+ years of experience
Source : Oxenham Group LLC
