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The Digital Product Engineering organization powers digital experiences and engagement to enhance the lives of millions of people every day through connected care. We build, deliver, and manage a divers portfolio of offerings supporting our core businesses. You'll be immersed in a dynamic, high-growth environment and empowered to excel, take informed risks, and drive ingenuity across the enterprise.
The Digital Engineering team is focused on improving patient outcomes and delighting our customers. We support customer workflows, access to patient management and clinical data, support patient engagement, and offer both UI and API-based solutions backed by cloud-native microservices. We focus on complete, end-to-end ownership of the software development lifecycle.
As a Compliance Engineer, you will work closely with our engineering managers, technical and feature leads, and scrum teams to provide engineering excellence in the areas of product compliance and audits. You will be responsible for developing and implementing the company's technical compliance capabilities according to local, national, and international regulatory standards. You will have a sound technical background and be up to date with the latest regulatory developments in the industry.
The Compliance Engineer will work with software development teams to ensure all regulatory and company requirements are met. The face of the Audits: Act as SME for all the audits for ResMed's digital products. Represent ResMed Engineering in audits, including but not limited to HDS, MDSAP, SOC2, and MDR.
Identify and evaluate technical design alternatives to achieve desired functionality in partnership with cross-functional team members and Systems Architecture Leaders.
Educate the engineering teams on the design review needs and facilitate the design review process among those teams. Help resolve technical issues.
Safety Risk Analysis: Drive the bug-triage process and help determine issues that impact patient safety. Participate in the product roadmaps and influence the release of features based on safety risk analysis. Act as a bridge between Product Engineering and ResMed Quality/Regulatory teams and bring knowledge on the latest safety-related standards.
Apply expert regulatory knowledge: Tackle intrinsically challenging problems with implication to regulatory requirements from around the world.
Ensure the company's technical compliance with applicable laws and regulations. Responsible for researching and identifying applicable regulatory and industry compliance standards and codes. Ensure product achieves performance, functionality and reliability as specified in the marketing and systems specification documents.
Deployments: Act as SME for formal releases to ensure meeting all the needed compliance and regulatory-related deployment documentation.
Post Market Risk Assessment: Prepare compliance reports by collecting, analyzing, and summarizing measurement data and trends related to post-launch market data.
BS/MS in any engineering discipline. Computer science preferred. No hands-on coding experience is needed.
- 3 years of experience delivering medical products and navigating through audits like MDR, SOC2, MDSAP, HDS, or any other regulatory framework is a plus
- Proficiency in report writing, analysis, and compliance procedures.
- Thorough understanding of regulatory frameworks.
- Solid technical knowledge and understanding of Software Product Life Cycle (SDLC).
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. 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 receive 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.
Where a culture driven by excellence helps you not only meet your goals, but also create new ones.
