Senior Product Quality Assurance Engineer (I&G)
ResMed
Summary
The Senior Design Quality Engineer ensures that new and existing digital health products from Incubation & Growth (I&G) areas comply with quality, safety, regulatory standards, and user requirements. He/She is specialized in design controls, overseeing verification and validation activities in alignment with internal quality management systems and external regulations. He/She should understand emerging technologies as part of I&G and supports the strategy from concept to commercial launch.
Job description
Responsibilities
- Perform specialized work applying principles and concepts related to digital health applications and I&G.
- Develop project QA plan to enable new product implementation or changes to the released product from I&G/Digital health area, in an efficient way that satisfies ResMed's Quality System, regulatory requirements (e.g. ISO13485, CFR820, MDR 2017/745), risk and project timing. Review and provide guidance to PD/Engineering/I&G teams for Product Development deliverables to ensure they are completed accurately and efficiently.
- Within the scope of the project, collaborate with other QA (including Post Market Quality and QA Production), Regulatory as well as I&G team members to provide updates, trainings and support effective QA guidance to the project team.
- Manage and contribute to digital health /I&G projects, providing clear executive summaries on project status.
- Offer guidance on quality matters associated with the design and development of digital/I&G 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 and Experience
Required
- 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), with ideally experience under an MDR/ISO 13485 environment.
- 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.
- Efficient, autonomous and flexible
- Good written, verbal communication and collaboration skills with an ability to negotiate and influence
Preferred
- 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.
Requirements
- 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), with ideally experience under an MDR/ISO 13485 environment.
- 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.
- Efficient, autonomous and flexible
- Good written, verbal communication and collaboration skills with an ability to negotiate and influence
- 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
- Medical, Dental & Vision
- Life Insurance
- AD&D Insurance
- Short-term Disability
- Long-term Disability
- Sleep Care Management
- Health Savings Account
- Flexible Spending Account
- Commuter Benefits
- 401(k)
- Employee Stock Purchase Plan
- Employee Assistance Program
- Tuition Assistance
- Paid Time Off
- Paid Holidays
- Caregiver Leave
Company overview
ResMed is a global leader in connected health solutions specializing in sleep apnea and respiratory care. Founded over 30 years ago, the company pioneers innovative cloud-connected medical devices and digital health technologies that transform care for millions of people worldwide. Headquartered in San Diego, California, ResMed operates in more than 140 countries with a team of over 10,000 employees. The company's comprehensive product portfolio includes CPAP machines, ventilators, masks, and accessories for treating sleep apnea, COPD, and other chronic respiratory conditions. ResMed's digital ecosystem features AI-powered platforms like AirView for remote patient monitoring and myAir for patient engagement, enabling personalized home healthcare. As a publicly traded company (NYSE: RMD, ASX: RMD), ResMed has established itself as the world leader in sleep health technology, with more than 30 million cloud-connectable devices in the market and over 23 billion nights of clinical respiratory data collected. The company's mission focuses on improving quality of life, reducing chronic disease impact, and lowering healthcare costs through innovative connected health solutions.