We are currently looking to hire a Senior Principal Design Assurance Engineer (DAE) for our client in Southern California. This position will serve as the Subject Matter Expert (SME) for the company with everything pertaining to design, quality and support of all new product development and sustaining projects.
As the SME you will be required to provide guidance to the business in interpreting and executing against the company"s Quality Management System and against domestic and international regulatory requirements to ensure compliance. Responsible for ensuring that all system-level project work for new products and for product changes (e.g., plans, requirements, specifications, protocols, tests methods, test results, risk management documents, reports) meet the company"s quality and compliance requirements. This role will ensure design assurance-driven initiatives meet objectives in delivering the highest quality products, with supporting tools and processes.
Below is a list of the key responsibilities for the role, whilst not exhaustive, that you"ll need to be able to perform;
- Constantly evaluates the Design Control, Change Control, and Risk Management procedures.
- Works with R&D, Engineering, Manufacturing, Regulatory functions to define requirements for new product development.
- Partners with R&D to determine and define design inputs, design outputs, and design input/output relationships.
- Participate and lead new product development phase reviews and design reviews.
- Create and support the development and validation of new test methods.
- Evaluate the impact of any new product or changes to existing products on regulatory applications.
- Supports Sustaining Engineering for design and process changes to commercialized product.
- Will fulfill the position of independent reviewer during the design review process.
- Drive the selection and qualification of new and/or existing suppliers; this may include execution of Quality Management System supplier audits.
- Drives the Risk Management process, leading the creation of deliverables such as Hazard Analyses, DFMEA, URRA, and PFMEA.
- Other duties as assigned.
This is an extremely robust role, that carries a high level of both autonomy and responsibility, in which you"ll be asked to create a technical strategy for medical device product and projects, ensuring cross functional leadership alignment is maintained. You will need a Bachelor's degree in Engineering or related discipline and 8+ years previous experience in the Medical Devices arena. Possession of relevant professional certifications related to quality systems and compliance for medical industry; ASQ and RAPS are preferred.
This is a great opportunity to challenge yourself within a growing, and dynamic, business who are at the forefront of cutting edge technology