Principal Design Assurance Engineer

Our start-up medical device client is adding a Design Assurance Manager to the team. The DA Manager works cross-functionally and is responsible for providing Design Assurance representation on teams, facilitating design verification and validation for transfer to manufacturing, and implementing process / product improvements. The manager also supports quality management system process development and execution for applicable processes. The role has shared responsibility for product safety and quality in all stages of product and process development, and ensuring compliance with design specifications, quality management system procedures associated with design assurance, and all applicable regulatory requirements.

Your role with the company :

Responsible for implementing measurement systems analysis and standardizing documented quality tools such as root cause analysis, flowcharts, cause and effect diagrams, control charts, APQP / PPAP, FMEA, DOE, and other applicable statistical methods.

• Responsible for developing, improving, and managing design assurance processes such as failure analysis, design verification and validation, risk management, design and process-related CAPAs, and complaint handling processes.
• Manage the risk management process by ISO 14971, including risk management plans, hazard analysis, user risk analysis, FMEAs, and risk management reports, throughout all product development phases.
• Responsible for tracking, analyzing, and reporting on quality and business measurements such as design verification failures, complaints, and CAPAs. Supports the analysis and evaluation of design verification capabilities and the design and development of new products from the design assurance perspective.
• Partner with other functional areas, primarily R&D, in areas such as preparing test plans, data analysis, specifications, risk analysis, proposed change assessments, and change implementation. Interpret and contribute to electro-mechanical systems, software design, and testing. Ensure clarity and consistency in acceptance criteria and ensure the verification processes used are capable and statistically relevant.

Manage People

Manage Products

Manage Processes

Desired Profile :

BS Engineering (EE, ME, BME) ideal

Certifications (ASQ CQE, SSBB, MQ / OE, CSCP, CQA)

Experience in statistics, statistical software, and Quality Tools a plus