Project Manager – AI Medical Devices

🔥 17 minutes ago

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Prenuvo

WebsiteLinkedInAll Job Openings

51 - 200 employees

💰 Debt Financing on 2022-10

Prenuvo is a fast growing health tech company specializing in whole body diagnostic imaging. We are a global leader in whole body MRI screening with a track record of early detection of cancer and other major health diseases.In an era of reactive and fragmented health screening, Prenuvo is rooted in early detection through cutting-edge imaging technology. Our technology brings together comprehensive scans, AI-augmented analysis, and protocols that have been honed over years of research and practice. Together, Prenuvo’s scans offer unparalleled diagnostic accuracy for you and your doctor.We empower people to make informed decisions about their health by putting comprehensive, consistent, and detailed scans in your hands. Simply put, we offer you a window into your own body.Prenuvo is one of the first scans to use artificial intelligence to build consistent, reliable, and standardized reports for the radiologists interpreting your scans.We provide faster, easier access to the clinically-significant insights needed to make more informed health decisions. We do it to help people live longer, better, healthier lives. A more comprehensive picture of your body enables you to feel empowered and advocate for yourself.

📋 Description

• Support project planning, scheduling and progress tracking for multiple AI device programs. • Collaborate closely with AI/ML engineers, systems engineers, regulatory affairs, product teams and clinical operations to keep deliverables synchronized across teams. • Maintain project documentation in Jira and other tools, track milestones and ensure all design control and regulatory deliverables are up to date. • Support readiness for regulatory submissions (such as 510(k), IDE, Health Canada) and plan/execute design control design reviews, including capturing clear summaries and follow-ups. • Provide regular updates on project progress, risks and dependencies to leadership. • Identify process gaps and contribute ideas to improve collaboration, documentation flow and delivery efficiency.

🎯 Requirements

• Minimum of 2 years of experience coordinating projects in a healthcare environment. • Familiarity with medical device lifecycle management, especially Software as a Medical Device (SaMD) development and verification. • Excellent organizational and time management skills with strong attention to detail. • Ability to manage multiple priorities and deadlines in a fast-paced, cross-functional environment. • Strong written and verbal communication skills to bridge technical, regulatory and business teams. • Proficiency with project tracking tools (such as JIRA) • Bachelor’s degree in Biomedical Engineering, Project Management, or a related technical or business discipline.

🏖️ Benefits

• An avenue to make a positive impact on people's lives and their health • Growth opportunities are at the heart of our people journey, we’re doing big things with bright minds - there is no single path to success, it can be shaped along the way • Building strong relationships is at the core of everything we do - our team gets together each week to connect, share, and socialize