Quality Assurance Engineer

Our mission at Oura is to empower every person to own their inner potential. Our award-winning products help our global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. By providing daily insights and practical steps to inspire healthy lifestyles, we've helped hundreds of thousands of people understand and improve their health. For us, empowering the world starts with living our values and empowering our team. As a quickly growing company focused on helping people live healthier and happier lives, we work to promote work-life balance and ensure that our team members have what they need to do their best work — both in and out of the office. We are looking for an Medical Device Quality Assurance Engineer to join the Medical Device team at Oura to help us ensure we are compliant with the applicable standards and regulations governing the development of medical device software. Internally we call this role the Quality Assurance Champion. This role will demand close collaboration with a cross-functional development team consisting of product management, science, clinical researchers, designers, SW developers and testers to ensure the software is developed, tested and documented to meet defined requirements. We are seeking a candidate with a strong personal drive of quality excellence and motivated by the desire to deliver important medical solutions that can improve the lives of millions of people across the globe. What you will do: Provide oversight for medical device software products through all phases of the development process, risk management, human factors and usability engineering, process development and verification/validation testing, as well as life cycle management during design changes. Guide the software development team to define critical safety and performance requirements. Lead the compilation, review and approval of all technical documentation for development and risk management documentation, e.g., planning, protocols, reports, risk assessments, testing, etc. by applying applicable company procedures and regulatory requirements. Support the timely handling of complaint investigations, change impact assessments, and CAPAs related to the projects under your governance. Support continuous improvement to the Quality Management System by identifying areas for improvement and engaging in remediation. Collaborate with Oura’s SaMD feature development teams by providing technical and quality support during the development, testing and deployment of software. Support internal and external audits and inspections as a subject matter expert. Perform a broad variety of tasks in support of the role and responsibilities. Location: In this role you can work remotely as well as from a variety of US based offices. Part of the role is communication with our team members in Finland, therefore a flexible work schedule is required. Requirements We would love to have you on our team if you have: Degree in: Biomedical/Mechanical Engineering or related technical or scientific discipline. 3+ years of experience working in a regulated environment under a medical device Quality Management System (21 CFR 820 or ISO 13485:2016). Working knowledge and application of device regulations (21 CFR 820 and EU MDR 2017/745). Expertise in software development and risk management standards (IEC 62304, ISO 14971). Experience in applying human factors and usability engineering to medical devices per ISO 62366-1. Experience with application of risk analysis tools (such as FMEA, or Fault Tree Analysis). Demonstrate ability to assess and provide technical guidance for software as a medical device (SaMD). Must be detail oriented with strong leadership skills and excellent interpersonal, collaboration and communication skills. You can sense and articulate why certain issues demand more diligence to ensure compliance to applicable regulations or standards. Together we will continue to define Oura as a company where you can: Be part of a world-class engineering team following and helping define best practices. Contribute to a product that improves the lives of millions of people across the globe. Be happy and have great work-life balance - we work efficiently, remove the fluff and pointless meetings, so that work continues to inspire and motivate you. Grow on your chosen career path, be it technical, people, managerial or leadership skills, or any mix of those. Benefits At Oura, we care about you and your wellbeing. Everyone here has an Oura Ring of their own and are continually looking to improve their health and add to our benefits! What we offer: Competitive Salary Wellness benefit Flexible working hours An Oura Ring of your own Personal learning & development program Wellness Time Off Oura is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees. Individuals seeking employment at Oura are considered without regards to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, socioeconomic status, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. We will not tolerate discrimination or harassment based on any of these characteristics. Oura takes a market-based approach to pay, which may vary depending on your location. US locations are categorized into tiers based on a cost of labor index for that geographic area. While most offers will be closer to the starting range, successful candidates' pay will be determined based on job-related skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the future. Region 1 $142,000 - $178,000 Region 2 $130,000 - $163,000 Region 3 $120,000 - $150,000 A recruiter can determine your zones/tiers based on your US location. We are not considering candidates residing in the following states: Alaska (AK), Delaware (DE), Iowa (IA), Mississippi (MS), Missouri (MO), Nebraska (NE), South Dakota (SD), Vermont (VT), West Virginia (WV), and Wisconsin (WI) Oura is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees. Individuals seeking employment at Oura are considered without regard to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. We will not tolerate discrimination or harassment based on any of these characteristics. We will work to ensure individuals with disabilities are provided reasonable accommodation to participate in the interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Disclaimer: Beware of fake job offers! We’ve been alerted to scammers posing as ŌURA recruiters, especially for remote roles. Please note: Our jobs are listed only on the ŌURA Careers page and trusted job boards. We will never ask for personal information like ID or payment for equipment upfront. Official offers are sent through Docusign after a verbal offer, not via text or email. Stay cautious and protect your personal details. To all recruitment agencies: Oura does not accept agency resumes. Please do not forward resumes to our jobs alias, Oura employees, or any other organization's location. Oura is not responsible for any fees related to unsolicited resumes.