Senior Technical Project Manager, Medical Devices

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 and developers to ensure the software is developed, tested and documented to meet defined requirements. While not a strict requirement, experience working with consumer software products or services is highly valued, as our Oura App and Ring are used by a broad consumer audience. 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.

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:

• →Responsible for the timeline, resourcing, and leadership status communications regarding program initiatives
• →Facilitate meetings and ensure program deliverables are identified and met on time
• →Act as a liaison between development teams and Quality Assurance Champion through all phases of the development process of SaMD
• →Be the primary driver of the SaMD Design History File (DHF) managing the DHF pipeline across multiple concurrent programs.
• →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 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:

• 6+ 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
• Have lived through full device lifecycle end-to-end
• 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.
• Ability to motivate and explain the importance of DHF documentation to teams that may be unfamiliar with their importance.
• Detail orientation with strong leadership skills and excellent interpersonal, collaboration and communication skills.
• Experience working with people of different cultures and experience - high EQ - while being empathetic to what motivates and empowers them.
• 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.

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.