Technical Project Manager, Medical devices

Our mission at Oura is to empower every person to own their inner potential. Our products help Oura members gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. We've helped over a million people understand and improve their health by providing daily insights and practical steps to inspire healthy lifestyles.

We are looking for an experienced 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 and developers 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.

Preferred location: Oulu or Helsinki.

What You will do:

While you are responsible for the technical project management, you also enjoy roll-up your sleeves and putting your hands in the mud. More specifically:

• 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.

What we hope from You:

We would love to have you on our team if you have a deep knowledge and experience on software development in a regulated field and ideally also understanding of consumer software products. More specifically:

• 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.
• 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.

Together we will continue to define Oura as a company where you can:

• Be productive and do your best work.
• 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

• Competitive compensation
• Flexible working hours
• Collaborative, smart teammates
• Lunch & Wellness benefits
• Personal learning and development program
• Wellness Time Off
• An Oura ring of your own
• Latest equipment

If this sounds like the next step for you, please send us your application and CV latest by May 26th 2024.

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.