Senior Technical Project Manager, Medical Devices
ŌURAFinland3 days ago
Full-timeRemote FriendlyProject Management, Information Technology
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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 millions of 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.
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.
Responsibilities
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:
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:
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.
Disclaimer: Beware of fake job offers!
We’ve been alerted to scammers posing as ŌURA recruiters, especially for remote roles. Please note:
To all recruitment agencies: Oura does not accept agency resumes. Please do not forward resumes to our jobs alias, Oura employees, or any other organization's location. Oura is not responsible for any fees related to unsolicited resumes.
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.
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.
Responsibilities
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.
- 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.
- Lunch benefit
- Wellness benefits
- Statutory accident insurance and additional free time insurance
- Travel insurance (business and leisure)
- Occupational Healthcare
- Wellness Time Off
- An Oura ring of your own & Life-time Oura membership
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.
Disclaimer: Beware of fake job offers!
We’ve been alerted to scammers posing as ŌURA recruiters, especially for remote roles. Please note:
- Our jobs are listed only on the ŌURA Careers page and trusted job boards.
- We will never ask for personal information like ID or payment for equipment upfront.
- Official offers are sent through Docusign after a verbal offer, not via text or email.
To all recruitment agencies: Oura does not accept agency resumes. Please do not forward resumes to our jobs alias, Oura employees, or any other organization's location. Oura is not responsible for any fees related to unsolicited resumes.
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