Advanced Sterilization Products (ASP), a member of Fortive, is recruiting for a Senior Electrical Quality Engineer, Product Development located in Irvine, CA.
You, the Senior Electrical Product Quality Engineer, Product Development will provide high performance quality engineering leadership and support for New Product Development and Life Cycle management project teams. This includes specific quality engineering support to the risk management, design verification and validation and design control processes. Preferably you will be an electrical engineer with Control Systems experience.
Under minimal supervision this position will:
- Collaborate with representatives from other functional areas to lead risk analysis, design control processes, and approve design validation and verification.
- Provide constructive technical challenge to the design and development and lifecycle management of a capital systems from a product/system and process perspective.
- Develop Risk Management Files including Hazard Analysis, FMEAs [Use, Design]. Lead identification of potential risks, failure modes and risk controls measures
- Support new product introduction, design changes and post launch.
- Provide support in Statistical Analysis for project teams.
- Lead complex investigations, coordinate technical teams to ensure sound experimental design, effective data analysis, risk analysis, design verification and validation and subsequent closure to technical investigations.
- Support, perform, or oversee Internal and External Audits, NCs and CAPAs. Provide support for 3rd Party Inspections and Audits.
- Serves as the technical expert for the organization in the application of advanced theories, concepts, principles, and processes for an assigned area of responsibility such as Design Control, Risk Management.
- A B.S. in Engineering with 4 or more years of related experience is required. Electrical Engineering with control systems experience strongly preferred. Other Engineering disciplines will be considered if experience aligns with stated qualifications.
- A Master's degree in Engineering discipline plus 2 or more years of related experience and/or training; or Ph.D. in an Engineering discipline is preferred.
- Systems engineering with software integration strongly preferred
- Engineering experience in an FDA-regulated industry (medical device, pharmaceutical, etc.) and working knowledge of 21 CFR Part 820 and ISO 13485 is preferred.
- Understanding ISO 14971 and FDA Guidance and thorough understanding in the application of risk management tools, such as, Risk Analysis, FMEA and FTA is preferred.
- Experienced in applying statistical methods and data mining, creating sampling plans and sample size calculations, and using data analysis in support of objective decision making is preferred.
- Strong understanding of Design Control and medical device product development is preferred.
- This position may require approximately 10% national and international travel and will be based in Irvine, California.