Staff Design Quality Assurance Engineer (Medical Device Software)

$110,000 - $110,000/Yr

Danaher - West Sacramento, CA

Full-time - Mid Level

Hybrid - West Sacramento, CA

Computer and Electronic Product Manufacturing

About the position

The Staff Design Quality Assurance Engineer at Beckman Coulter Diagnostics plays a crucial role in supporting the software product design and development lifecycle within the Microbiology Business Unit. This position is integral to the US Diagnostics Development Quality (Design Assurance) team, reporting directly to the Manager of Design Quality Assurance. The primary objective of this role is to ensure that high-quality, reliable, and regulatory-compliant products are developed to meet the needs of clinical customers and support Beckman's business growth objectives. The engineer will engage in various phases of product development, collaborating with cross-functional teams to define performance requirements, conduct risk analyses, and establish verification test plans. In this role, the engineer will facilitate risk assessments for new designs and design changes, ensuring compliance with regulatory agency requirements and company policies. The engineer will also be responsible for maintaining an auditable and organized Design History File (DHF) that supports regulatory product registration needs. Continuous improvement of new product development procedures and methods is a key focus, as the engineer will drive efficiencies in project-specific processes. This position offers a unique opportunity to contribute to a world-class Quality organization in a fast-paced and diverse environment, making a significant impact on patient lives through innovative diagnostic tools.

Responsibilities

• Fulfill the Development QA / Design Assurance role on Software Product Development Core and/or Design Change Teams as the design progresses through the development lifecycle.
• Collaborate constructively with other functional group team members to define performance requirements, conduct risk analysis, and establish right-size verification test plans.
• Facilitate risk assessments for new designs and design changes at various project development phases.
• Ensure compliance with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project-specific plans.
• Assure the product Design History File (DHF) is auditable, traceable, concisely organized, complete, and supports regulatory product registration needs.
• Drive continuous improvement of new product development procedures, methods, tools, techniques, training, etc., to support project-specific efficiencies.

Requirements

• BS in Software Engineering or related technical field with 9+ years of experience, a Master's degree in a field with 7+ years of relevant experience, or a Doctoral degree with 4+ years of experience.
• 1-2 years of experience within product design and/or manufacturing environment supporting software/hardware development projects.
• Proven knowledge of design control processes, including design change, risk management, design requirements, design V&V, and design transfer.

Nice-to-haves

• Previous experience in Artificial Intelligence or Machine Learning.
• Experience in Quality Assurance.
• Familiarity with Agile Development.
• Experience in a regulated industry, specifically knowledge of IVD and the Medical Device industry.

Benefits

• Paid time off
• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) plan
• Bonus/incentive pay