Senior Product Quality Assurance Engineer (I&G)

ResMed • San Diego, CA

55d • $122,000 - $184,000

About The Position

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.

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

Nice To Haves

• 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.

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.

Benefits

• 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.
• fifteen days Paid Time Off (PTO) in their first year of employment
• 11 paid holidays plus 3 floating days
• 14 weeks of primary caregiver or two weeks of secondary caregiver leave

What This Job Offers

• Job Type: Full-time
• Career Level: Senior