Software Design Quality Assurance Engineer

Philips • Bothell, WA

1d • $102,480 - $163,968 • Onsite

About The Position

The Software Design Quality Assurance Engineer is responsible for developing, maintaining, and managing comprehensive software quality documentation, such as Software Requirement Specifications (SRS), ensuring their accuracy and regulatory compliance throughout the software lifecycle. Your role: Leads the assessment of software designs by reviewing test and performance data to uphold quality, safety, and regulatory standards, and address any engineering deficiencies. Conducts detailed root cause analyses for software quality issues and validating key design inputs like usability, reliability, and performance. Implements software quality plans and risk management activities, utilizes post-market analytics to monitor software performance, and initiates corrective actions as needed. Develop global regulatory strategies by creating and implementing regulatory roadmaps aligned with market trends, legislation, product marketing objectives and staying current on evolving regulations to advise senior leadership on strategic decisions. Be a regulatory authority liaison, acting as the business unit contact with regulatory bodies, ensuring clear communication and fostering relationships to influence decisions and secure approvals. Lead our regulatory compliance team by providing guidance, managing talent, and driving succession planning and growth while maintaining compliance and achieving organizational goals. Ensure compliance across the product lifecycle by overseeing regulatory planning and execution for new products and changes as well as managing filings and approvals by overseeing preparation and submission of documentation for global registrations to enable timely market access. Drive regulatory excellence and continuous improvement by developing plans, assessing risks, implementing actions, and optimizing regulatory processes for efficiency while maintaining high compliance standards.

Requirements

• You have a minimum of 3+ years’ experience in FDA regulated, IEC 62304 medical device software environments, with a focus on Software Design Assurance/Controls, knowledge of Risk Management (ISO 14971), SDLC and experience in Mobile Applications and/or SaMD is preferred.
• You have proven experience in Software Design Verification/Validation, Root Cause analysis and Defect Management.
• You have detailed experience in identifying, promoting, and supporting processes and design quality tools for use in tracking/preventing software defects, design traceability, Design for Reliability (DfR), Agile, and SAFe.
• You’re able to share knowledge, insights regarding software quality standards, and regulatory requirements.
• You have a minimum of a Bachelor’s Degree (Required), in Quality, Computer Science/Engineering or similar disciplines.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
• US work authorization is a precondition of employment.
• For this position, you must reside in or within commuting distance to Bothell, WA.

Nice To Haves

• experience in Mobile Applications and/or SaMD is preferred.
• ISTQB certification desired.

Responsibilities

• Leads the assessment of software designs by reviewing test and performance data to uphold quality, safety, and regulatory standards, and address any engineering deficiencies.
• Conducts detailed root cause analyses for software quality issues and validating key design inputs like usability, reliability, and performance.
• Implements software quality plans and risk management activities, utilizes post-market analytics to monitor software performance, and initiates corrective actions as needed.
• Develop global regulatory strategies by creating and implementing regulatory roadmaps aligned with market trends, legislation, product marketing objectives and staying current on evolving regulations to advise senior leadership on strategic decisions.
• Be a regulatory authority liaison, acting as the business unit contact with regulatory bodies, ensuring clear communication and fostering relationships to influence decisions and secure approvals.
• Lead our regulatory compliance team by providing guidance, managing talent, and driving succession planning and growth while maintaining compliance and achieving organizational goals.
• Ensure compliance across the product lifecycle by overseeing regulatory planning and execution for new products and changes as well as managing filings and approvals by overseeing preparation and submission of documentation for global registrations to enable timely market access.
• Drive regulatory excellence and continuous improvement by developing plans, assessing risks, implementing actions, and optimizing regulatory processes for efficiency while maintaining high compliance standards.

Benefits

• Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.
• Details about our benefits can be found here .

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level