Senior Program Manager, SaMD

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

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.This is a remote US role with a slight preference for candidates based in the East Coast.

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

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 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 $162,000 - $203,000
• Region 2 $150,000 - $187,000
• Region 3 $139,000 - $147,000

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), Rhode Island (RI), 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.

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