engineering
Posted Mar 16Senior Product Quality Assurance Engineer (Hybrid)
at ResMed
San Diego United States, United StatesOn-site
Requirements
- They have the ability to have strong emotional intelligence capability with expert negotiation skills. Let’s talk about
- 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, with guidance in only the most complex situations Frequently leads sub-functional teams or projects and train and mentor junior team members 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 5 years of
- experience OR a Master's degree in engineering with minimum of 3 years of experience.
- Advanced knowledge of FDA design controls for new product development with sound knowledge on phase gate design approach.
- Experience with digital health software applications required with working knowledge of IEC62304 and IEC82304.
- Basic to intermediate understanding of Artificial Intelligence tools such as VS Code, GitHub Copilot and ChatGPT required.
- Experience with conducting internal and external audits required. Prior
- experience as a key backroom audit member required (i.e. scribe, document reviewer).
- 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: 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.