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.
What You'll Do
- 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.
What You Bring
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
What Sets You Apart
- 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.
Why Join ResMed
We are shaping the future at ResMed, and we recognize the need to build on and broaden our existing skills and continue to attract and retain the world’s best talent. We work hard to offer holistic 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. Employees scheduled to work 30 or more hours per week are eligible for benefits. This position qualifies for the following 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.
Individual pay decisions are based on a variety of factors, such as the candidate’s geographic work location, relevant qualifications, work experience, and skills.
At ResMed, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current base range for this position is: $122,000 - $184,000
Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!