Project Manager (PMI Certified) – Software as a Medical Device (SaMD)

About Prenosis

Prenosis Inc. is an artificial intelligence company pioneering precision medicine in acute care. Our Immunix™ precision medicine platform drives the development of precision products and enables real-time delivery of optimal therapy. We've created and validated the first FDA-authorized AI biomarker for sepsis, the Sepsis ImmunoScore™.

At Prenosis, we:

• Put patients first

• Disrupt with evidence

• Excel with integrity

• Go far together

Our staff collectively defined these corporate values to demonstrate how our teams contribute to meaningful and authentic change in U.S. healthcare. We value our diverse talent, strive to foster a culture of continuous learning, and aim to maintain a feeling of belonging and shared sense of purpose.

Prenosis is headquartered in Chicago Illinois and generally operates on Central Time Zone.

Prenosis is seeking a PMI-certified Project Manager with strong experience leading projects in FDA-regulated SaMD environments. The ideal candidate brings disciplined project leadership, a solid understanding of medical device regulatory requirements, and the ability to coordinate highly technical, cross-functional teams.

You will drive successful execution of software products used for processing clinical data, executing AI biomarkers, and enabling research within hospital environments, ensuring delivery on time, within scope, and in compliance with quality and regulatory standards such as FDA 21 CFR Part 820, IEC 62304, ISO 14971, and ISO 13485.

Responsibilities

Project Leadership & Delivery

• Lead end-to-end planning and execution of SaMD development projects, including scope definition, scheduling, budgeting, resource planning, project risk management, and project change control.

• Work closely with Product Management, Engineering, R&D, Data Science, Quality, and Regulatory teams to build, manage, and maintain comprehensive project plans that support platform development for clinical data processing, AI biomarker execution, and hospital-based research workflows.

• Manage multidisciplinary project teams (Software Engineering, QA/RA, Clinical, Cybersecurity, DevOps, Data Science) to ensure timely and coordinated delivery.

• Develop and maintain project documentation including project charters, timelines, communication plans, decision logs, and dashboards.

• Coordinate stage-gate reviews and support alignment with design control requirements across the full development lifecycle.

• Ensure that all project activities meet applicable safety, quality, and regulatory standards.

Regulatory & Quality Compliance

• Support adherence to 21 CFR 820,, ISO 13485, IEC 62304, ISO 14971, and internal SOPs throughout the development lifecycle.

• Support regulatory submissions (including 510(k), De Novo, PMA) through planning, documentation readiness, and cross-functional coordination.

Communication & Stakeholder Management

• Serve as the central point of communication for project status, timelines, risks, and dependencies.

• Deliver clear executive summaries, traceable status reports, and KPI-driven progress updates.

• Coordinate effectively with internal teams, external partners, hospital collaborators, and vendors.

• Manage expectations through transparent communication and data-driven forecasting.

Risk, Resource & Vendor Management

• Proactively identify, assess, and mitigate project risks through structured risk management processes.

• Work with functional leaders to forecast resource needs, identify gaps, and support staffing planning.

• Ensure platform development aligns with cybersecurity, privacy, usability, interoperability, and post-market requirements.

• Support Supplier Quality compliance by ensuring vendor management aligns with internal procedures.

Expected frequency and duration of travel: Once per quarter

Qualifications and Experience

Required:

• PMI certification required (PMP, PgMP, or PMI-ACP).

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field (Master’s preferred).

• 5+ years of project management experience in a regulated medical device or healthcare technology setting.

• Hands-on experience managing SaMD projects, including design control, verification/validation, and risk management.

• Strong working knowledge of:

  • FDA 21 CFR Part 820

  • ISO 13485

  • IEC 62304

  • ISO 14971

  • AAMI TIR 45

• Demonstrated success managing complex, multidisciplinary programs with multiple technical stakeholders.

• Excellent communication, leadership, facilitation, and problem-solving skills.

• Proficiency with project management tools such as Smartsheet and Jira.

Preferred:

• Experience contributing to or managing 510(k), De Novo, or PMA submissions.

• Experience with Precision Medicine or Pharmaceutical Regulatory Requirements and submissions are a plus.Experience with Agile, hybrid, or iterative SDLC methodologies in regulated environments.

• Familiarity with AI/ML-based SaMD, cloud technologies, and digital health platforms.

• Experience supporting HIPAA compliance, cybersecurity activities, and post-market surveillance.

• Additional certifications (CSM, SAFe, Lean/Six Sigma) are a plus.

What We Offer

• Comprehensive Medical, dental, and vision coverage

• 401(k) with company match

• Unlimited PTO

• Major opportunity for career development to make significant impact at an exciting growth-stage company

• Collaborative and innovative work environment

• Chance to make a real impact on patient care

• Opportunity to work on cutting-edge AI technology in healthcare

Prenosis is an Equal Opportunity Employer

Must be eligible to work in the US without sponsorship