Design Assurance Engineer
The Sr. Design Assurance Engineer will be responsible for leading complex projects and activities to assure quality is designed-in to the new product and in the product life-cycle. With comprehensive knowledge of engineering and problem-solving principles, he/she will apply “good engineering practices” that will not only meet regulations and standards but exceed customer satisfaction. This role is based in Brea, CA and works within a cross-functional, matrixed global organization to drive dynamic performance in all areas.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Actively participates in defining customer requirement, product claims and target markets early in the product development life-cycle.
- As a Product Development Core Team member, proactively influence designs to achieve product quality and reliability targets that meet or exceed customer expectations
- Lead complex technical problems where analysis of situations or data requires an in-depth evaluation of various factors and solve a wide range of difficult problems in creative and effective ways.
- Develops or participates in establishing requirements for all verification and validation (design and process) activities
- Apply state-of-the-art inspection and quality engineering/assurance techniques, procedures, instruments, equipment, theories, principles and concepts to products and processes
- Leads development of Risk Management documentation.
- Leads/participates in data collection, analysis, trending and reporting on non-conformances and investigations to determine root cause, corrective and preventive actions.
- Mentors junior Design Assurance Engineers as required.
- Participates in audits and inspections of the company and our quality systems.
- Bachelor’s degree in an Engineering, or similar discipline.
- Minimum of 5 years in an FDA regulated product design and development environment; medical device experience industry high preferred.
- Solid understanding of design controls and risk management (ISO 13485, 21 CFR 820 and ISO 14971).
- Proficient in Statistical analytics, Advanced SPC, Quality Analysis Tools and DOE.