The Design Assurance Engineer is a core member of multidisciplinary new product development teams and is responsible for quality assurance elements of new product development. Key activities include assuring the product design conforms to user requirements and applicable standards, assuring that the product design minimizes risk, and assuring the product design is adequately tested and evaluated. This requires providing support during the design and development process as well as evaluation of product or process changes and post-market surveillance information.
- Serve a design assurance resource for an assigned Strategic Business Unit
- Assist with the establishment of customer focused design specifications to ensure they adequately address clinical, engineering, and marketing requirements.
- Assure compliance of design control system and product specifications with applicable ISO/EN standards, FDA QSR, European MDD, and applicable international requirements
- Actively participate in the preparation of risk analysis documentation, hazards analysis, failure modes analysis, and quality plans.
- Design verification and validation strategy development and review and approval of validation and verification plans and testing activities, including simulated use testing and clinical evaluation.
- Participate in periodic design reviews during the development process and coordinate postmarket surveillance design reviews to assure continued compliance with design requirements.
- Provide statistical data analysis support.
- Assist with the development of internal quality control inspections and implementation of appropriate measurement methods and test equipment.
- Review proposed product and process changes to assess their effect on design requirements and to ensure the adequacy of the supporting testing.
- Coordinate failure investigations and root cause analysis for product complaints and other postmarket surveillance product performance information.
- Assist the Quality Assurance department with issues related to quality engineering, statistical process control, nonconforming materials, process validations, and audits.
- Knowledge of statistical analysis techniques.
- Working knowledge of requirements of current ISO 13485 standard & FDA cGMP/QSRs
- Excellent organizational and time management skills
- Strong verbal and written communication skills.
- Bachelor of Science or Engineering degree preferred
- 5+ years experience as a Design Assurance Engineer, Quality Engineer or Product Development Engineer in the medical device industry with class II or class III products.
- Certified Quality Engineer (CQE) is desirable.
- Experience with new product development, design requirement development, design verification/validation testing, and risk management techniques.