Senior Product Quality Assurance Engineer – I&G

🕒 Yesterday

🇺🇸 United States – Remote

💵 $122k - $184k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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ResMed

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1989

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 Post-IPO Debt on 2019-07

Healthcare • Manufacturing • Healthcare Insurance

ResMed is a global leader in sleep technology and respiratory care, focused on improving out-of-hospital care to enhance the health and quality of life for individuals with chronic diseases. With over 30 years of innovation, ResMed develops life-changing technology and provides software platforms that support medical professionals and caregivers in helping patients manage their health from home or in preferred care settings. The company is committed to diversity and inclusion, supporting a wide range of professionals in building meaningful careers, and shaping the future of connected health care with the goal of impacting 250 million lives worldwide.

📋 Description

• Ensure new and existing digital health products from Incubation & Growth areas comply with quality, safety, regulatory standards, and user requirements • Oversee design controls and verification and validation activities in alignment with quality systems and external regulations • Support product strategy from concept through commercial launch • Perform specialized quality assurance work related to digital health applications and I&G • Develop project QA plans for new product implementation or released-product changes • Ensure compliance with ResMed’s Quality System, regulatory requirements, risk controls, and project timing • Review and guide Product Development, Engineering, and I&G teams on product development deliverables • Collaborate with QA, Post Market Quality, QA Production, Regulatory, and I&G team members • Provide project updates, training, and QA guidance • Manage and contribute to digital health and I&G projects • Provide clear executive summaries on project status • Advise on quality matters for digital health product design and development • Influence strategy and drive business outcomes • Build relationships beyond the immediate area of expertise • Work independently on daily projects and tasks • Act as a best-practice resource • Participate in internal and external audits to ensure regulatory and standards compliance

🎯 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 • Hands-on experience taking a product from concept to production using a phase gate approach • Ideally, experience under an MDR/ISO 13485 environment • Advanced knowledge of IEC 62304 • 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 scribe, lead backroom document reviewer, or front room SME roles • Efficient, autonomous, and flexible • Good written and verbal communication and collaboration skills, with 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 for digital health software application testing

🏖️ Benefits

• Comprehensive medical, vision, dental, and life insurance • AD&D insurance • 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) • Tuition assistance • Fifteen days Paid Time Off (PTO) in the first year • 11 paid holidays plus 3 floating days • 14 weeks of primary caregiver leave or two weeks of secondary caregiver leave • Flexible work arrangements • Opportunities for personal and professional growth • Diverse and inclusive workplace culture