Job Description

Summary

We are seeking a dynamic and experienced Senior Project Manager to lead critical software and firmware projects within a digital and device ecosystem. In this role, you will oversee the onboarding of hospital clients to a secure cloud platform, lead the firmware development lifecycle for a medical device, and manage the ongoing success of a secure device-to-on-prem app and middleware system. The ideal candidate is a seasoned project manager with expertise in healthcare technology, FDA-regulated product development, and a deep understanding of both Agile and traditional project management methodologies.

Responsibilities

• Project & Program Management: Lead the execution of major and minor projects across hardware, firmware, software, and platform initiatives. Develop and maintain integrated project plans for the digital solution ecosystem.
• Agile Leadership: Act as Scrum Master for Agile software projects, facilitating sprint planning, backlog grooming, sprint reviews, and retrospectives.
• Cross-Functional Coordination: Collaborate with external vendors, clinical teams, and internal stakeholders to ensure milestone delivery and quality standards. Act as the liaison between product, engineering, regulatory, and customer success teams.
• Vendor & Partner Management: Oversee external vendors for software development, cybersecurity, and UI/UX design. Establish and maintain a vendor management framework with KPIs and regular cadence reviews.
• FDA Compliance & SaMD Oversight: Ensure that projects comply with FDA regulations for Class I/II medical devices and Software as a Medical Device (SaMD). Maintain traceability between requirements, design inputs, risk management, and verification/validation (V&V) activities.
• Stakeholder Engagement: Communicate project status, risks, and mitigation plans to executive leadership and cross-functional teams. Create and present project dashboards, Gantt charts, and KPI reports.
• Security & Compliance: Ensure adherence to HIPAA, SOC 2 Type II, HITRUST CSF, and FDA cybersecurity requirements, including risk management and secure software development practices.

Qualifications

• Experience: 7-10 years managing software and/or device development projects, preferably in regulated healthcare environments or medical technology.
• Certifications: PMI PMP or CAPM certification strongly preferred; Certified Scrum Master (CSM).
• Medical Device Expertise: Experience with FDA-regulated Class I/II medical devices, 21 CFR Part 820, ISO 13485, and/or IEC 62304 is highly desired.
• Skills: Strong leadership abilities, excellent problem-solving skills, and the capacity to manage multiple priorities simultaneously.
• Security Knowledge: Deep understanding of HIPAA Privacy and Security Rules, SOC 2 Type II, HITRUST CSF, and FDA cybersecurity requirements. Familiarity with secure software development lifecycle practices and AWS security architecture.
• Education: Bachelor’s degree in Engineering, Computer Science, Business, or a related field. An advanced degree (MBA, MS) is a plus.
• Communication: Exceptional written and verbal communication skills with the ability to engage executive leadership and cross-functional teams.
• Travel: Willingness to travel occasionally for vendor site visits, customer onboarding, and conferences.

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