Senior Product Quality Assurance Engineer

About the role

The Senior Design Quality Engineer ensures that new and existing digital health products comply with quality, safety, regulatory standards, and user requirements. They specialize in design controls, overseeing verification and validation activities in alignment with internal quality management systems and external regulations.

Responsibilities

• Perform specialized work applying principles and concepts related to digital health applications.
• Manage and contribute to digital health projects, providing clear executive summaries on project status.
• Offer guidance on quality matters associated with the design and development of digital health products.
• Utilize professional expertise and relationships to influence strategy and drive business outcomes.
• Network and build strong relationships beyond their immediate area of expertise.
• Work independently on daily projects and tasks.
• Act as a best practice resource within their area of expertise.
• Participate in internal and external audits to ensure compliance with relevant regulations and standards.

Qualifications

• Bachelor's degree in engineering with at least 5 years of experience or Master's degree in Engineering with at least 3 years of experience.
• Advanced knowledge of FDA design controls and hands on experience taking a product from concept to production (utilizing phase gate approach).
• Advanced knowledge of IEC 62304 (software standard).
• Proficiency with AI tools such as VS Code, GitHub Copilot, and ChatGPT.
• Working knowledge leading or supporting CAPAs, NCRs, and Issue Impact Assessments.
• Advanced proficiency with risk management tools and demonstrated application during the design phase lifecycle.
• Experience conducting internal and external audits, including roles such as scribe, lead backroom document reviewer and front room SME.

Preferred Qualifications

• Experience with digital health SaMD applications and IEC 82304.
• Working knowledge of creating and deploying custom AI agents.
• Prior experience utilizing JIRA and Confluence in a software product application environment.
• Understanding of statistical analysis related to sample sizes as related to digital health software application testing.

Benefits

• Comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance
• Sleep care management
• Health Savings Account (HSA), Flexible Spending Account (FSA), and commuter benefits
• 401(k) and Employee Stock Purchase Plan (ESPP)
• Employee Assistance Program (EAP) and tuition assistance
• Fifteen days Paid Time Off (PTO) accrued in the first year of employment
• 11 paid holidays plus 3 floating days
• 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members

Pay

A reasonable estimate of the current base range for this position is $122,000 - $184,000. Individual pay decisions are based on a variety of factors, such as the candidate's geographic work location, relevant qualifications, work experience, and skills.