Software Design Quality Assurance Engineer

Job Title
Software Design Quality Assurance Engineer

Job Description

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.

You're the right fit if:

• 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. ISTQB certification desired.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together:

We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an Office role.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details:

• The pay range for this position in Bothell, WA is $102,480 to $163,968.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. 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.

Additional Information:

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
• Company relocation benefits WILL NOT be provided for this position. For this position, you must reside in or within commuting distance to Bothell, WA.
• May require travel up to 10%.

#LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.