Senior Technical Project Manager, SaMD - Remote

Overview

Our mission at Oura is to empower every person to own their inner potential. Our award-winning products help our global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. We've helped 2.5 million people understand and improve their health by providing daily insights and practical steps to inspire healthy lifestyles.

Empowering the world starts with living our values and empowering our team. As a quickly growing company focused on helping people live healthier and happier lives, we ensure that our team members have what they need to do their best work — both in and out of the office.

In Short

• 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.

Requirements

• 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

• 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