Senior Technical Project Manager, Medical Devices
ŌURA
full-time
Posted on:
Location Type: Hybrid
Location: Helsinki • Finland
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Job Level
Tech Stack
About the role
- 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.
Requirements
- 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.
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
project managementsoftware as a medical device (SaMD)DHF documentationrisk management documentationtraceability matrixprotocolsrisk assessmentstestingregulatory requirementsfull device lifecycle
Soft Skills
leadershipinterpersonal skillscollaborationcommunicationorganizational skillsprioritizationexecutionempathymotivationdetail orientation
Certifications
ISO 13485:201621 CFR 820