engineering
Posted 4 weeks agoProduct Quality Assurance Engineer (Hybrid)
at ResMed
San Diego United States, United StatesHybrid
Requirements
- Responsibilities Performs work in a specialized area of expertise that requires knowledge of principles and concepts for digital health applications.
- (3) Leveraging professional expertise and relationships to contribute to strategy and drive business results Networking and building strong relationships with contacts outside own area of expertise Ability to work independently on day-to-day projects and tasks Serves as a best practice resource within own area of work Let’s talk about Qualifications and
- Experience Required: Bachelor’s degree in engineering with minimum of 3 years of
- experience Knowledge of FDA design controls for new product development with experiencing utilizing phase gate design approach Working knowledge of IEC62304 Basic to intermediate understanding of Artificial Intelligence tools such as VS Code, GitHub Copilot and ChatGPT required
- Experience leading/supporting CAPAs, NCRs and Issue Impact Assessments
- Experience with risk management tools with clear demonstration of using risk management within the design phase lifecycle Preferred: Masters degree in Engineering
- Experience with digital health software applications and IEC82304
- Experience with conducting internal and external audits required. Prior
- experience as a key backroom audit member is ideal (i.e. scribe, document reviewer) Advanced knowledge of AI Tools with prior working knowledge of building AI agents. Previous
- experience creating dashboards using JIRA and Confluence.
- Knowledge of statistical analysis with relation to sample sizes.
Benefits
- benefits packages, provide flexible work arrangements, cultivate a workforce culture that allows employees to grow personally and professionally, and deliver competitive salaries to our team members.
- benefits package: 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), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance.
- Employees accrue fifteen days Paid Time Off (PTO) in their first year of employment, receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members.