Senior Technical Project 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 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.

Requirements

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.

Benefits

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 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 - $174,000

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 cele