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Senior Technical Project Manager, SaMD at Oura. At Oura, our mission is to empower every person to own their inner potential. With our award-winning Oura Ring and app, we help over 2.5 million people turn insights about sleep, activity, and readiness into healthier, more balanced lives. We believe that starts from within — by creating a culture where our team feels supported, included, and inspired to do their best work. . Our values. guide how we show up for each other and our community every day.. We are looking for an experienced Senior Technical Project Manager to join the team to help us ensure we are compliant with the applicable standards and regulations governing the development of medical device software at Oura. This role will demand close collaboration with software designers,developers, and data scientists 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: . . Act as a liaison between development teams and Quality Assurance Champion through all phases of the development process. . Collaborate with Oura product and software developers working on regulated products by providing technical and quality support during the design, development, testing and deployment of software.. . Provide technical domain support to guide the software development team to define critical safety and performance requirements.. . Lead the construction, review and approval of all technical (DHF) documentation for development and risk management documentation, e.g., planning, traceability matrix, protocols, reports, risk assessments, testing, etc. by applying applicable company procedures and regulatory requirements.. . Perform a broad variety of tasks in support of the role and responsibilities.. . We have offices in San Francisco, San Diego, and Los Angeles for those who prefer hybrid or office settings. Oura employees in other major cities (like Boston and New York) occasionally gather informally at local co-working locations. This role will be heavily biased to those working in the US East Coast timezone.. We would love to have you on our team if you have:. . 5+ years of experience working in a regulated environment under a medical device Quality Management System (21 CFR 820 or ISO 13485:2016) as a project manager.. . Degree in Biomedical/Computer Science or related technical or scientific discipline.. . Demonstrated ability to assess and provide technical guidance for software as a medical device (SaMD).. . Ability to grasp and bind holistic architecture across different contexts (App, cloud, IT, algorithms, FW,..) . . Demonstrated strong skills to organize, prioritize, and execute.. . Detail orientation with strong leadership skills and excellent interpersonal, collaboration and communication skills.. . Ability to sense and articulate why certain issues demand more diligence to ensure compliance to applicable regulations or standards.. . Understanding on regulatory inspections and interaction with regulatory authorities.. . Company Location: United States.