Product Quality Assurance Engineer; Hybrid

The primary role of a Junior Design Quality Engineer ensures new and sustaining products meet quality and safety standards, regulatory requirements, and user needs to support the design and development of digital health products. They specialize in design controls ensuring verification/validation activities meet internal quality management system policies and procedures as well as external regulations and standards.

• Contributing to and managing digital health projects, providing clear executive summaries on overall health.
• Providing advice and direction on quality‑related topics related to design and development.
• Leveraging professional expertise and relationships to contribute to strategy and drive business results.
• Building and maintaining strong relationships with contacts outside own area of expertise.
• Working independently on day‑to‑day projects and tasks.
• Serving as a best practice resource within own area of work.

• Bachelor’s degree in engineering and at least 3 years of experience.
• Knowledge of FDA design controls for new product development, with experience utilizing a phase‑gate design approach.
• Working knowledge of IEC
  62304.
• Basic to intermediate understanding of AI tools such as VSCode, Git Hub Copilot, and ChatGPT.
• Experience leading or supporting CAPAs, NCRs, and issue impact assessments.
• Experience with risk‑management tools and demonstration of use during the design lifecycle.
• Experience conducting internal and external audits, including roles such as audit member, scribe, or document reviewer.
• Advanced knowledge of AI tools and building AI agents.
• Experience creating dashboards using JIRA and Confluence.
• Knowledge of statistical analysis related to sample sizes.
• Master’s degree in engineering (preferred).
• Experience with digital health software applications and IEC
  82304 (preferred).

Base salary range $83,000 – $125,000, plus eligible benefits for employees scheduled to work 30 or more hours per week.

• Comprehensive medical, vision, dental, and life insurance.
• AD&D, short‑term and long‑term disability insurance.
• Sleep care management.
• Health Savings Account (HSA) and Flexible Spending Account (FSA).
• Commuter benefits.
• 401(k) plan.
• Employee Stock Purchase Plan (ESPP).
• Employee Assistance Program (EAP).
• Tuition assistance.
• Paid Time Off (15 days in first year) and 11 paid holidays plus 3 floating days.
• Primary caregiver leave (14 weeks) and secondary caregiver leave (2 weeks).

We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace.