Senior Program Manager, SaMD

Job Description

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 a Senior Program 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 a sense of leadership and close collaboration across all stakeholders to ensure the software is developed, tested, documented, and delivered 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

• Define project scope, goals, and deliverables in collaboration with Medical Device Team, Oura’s SaMD feature development team Product Manager, senior management and stakeholders
• Develop project plans, including timelines, milestones, resource allocation, and budgets
• Coordinate cross-functional teams (TPMs, quality assurance champions, regulatory, Science, Research Ops, legal, etc.)
• Coordinate preparation and submission of regulatory documents (510(k), PMA, CE Mark, etc.) with Regulatory Affairs and QAC
• Monitor program progress and adjust plans as needed to meet objectives
• Identify, assess, and mitigate program risks (Value, Business, Feasibility, Usability and Regulatory)
• Serve as the primary point of contact for stakeholders and facilitate communication between technical teams, business units, and external partners (CROs, etc.)
• Develop and manage project budgets; track expenditures and forecast future needs
• Oversee all phases of the Software as a Medical Device product lifecycle (Context, Discovery, Development and Delivery) in alignment with the Design Controls and Regulatory pathway
• Resolve conflicts and remove obstacles to team progress
• Foster a culture of continuous improvement and high performance

Location

• Remote US
• Slight preference for candidates based in the East Coast.
• We have offices in San Francisco, and 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.

Requirements

We would love to have you on our team if you have:

• Degree in Biomedical/Mechanical Engineering or related technical/scientific discipline
• 7+ years of experience in project/program management
• Experience with Quality Management Systems
• Experience with medical device regulations and standards
• Experience with risk management
• Experience with medical device software development (IEC 62304)
• Excellent leadership, interpersonal, collaboration, and communication skills
• Ability to understand and articulate the need for diligence in ensuring regulatory and standards compliance
• Strong organizational, prioritization, and execution skills
• Detail-oriented

Salary

• $162,000

Benefits

At Oura, we care about you and your well-being. Everyone here at Oura has a ring of their own and we are continually looking to improve employee health. What we offer:

• Competitive salary and equity packages
• Health, dental, vision insurance, and mental health resources
• An Oura Ring of your own plus employee discounts for friends & family
• 20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off
• Paid sick leave and parental leave
• 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 region.