We are seeking a Program Manager, Digital Solutions to lead software-focused product development initiatives supporting connected medical devices, digital health technologies, and Software as a Medical Device (SaMD) solutions. This role partners closely with Software Engineering, Systems Engineering, Quality, Regulatory Affairs, Clinical Engineering, Product Management, and Cybersecurity teams to deliver innovative, compliant, and high-quality products that improve patient care.
The successful candidate will be a strong program leader with experience driving software development projects, managing cross-functional teams, and enabling predictable execution within a regulated environment.
What You'll Work On
Lead software and digital product development programs from planning through product release.
Drive execution across Software Engineering, Systems Engineering, Quality, Regulatory Affairs, Clinical Engineering, Product Management, and Cybersecurity teams.
Develop and maintain integrated project plans, schedules, milestones, resource forecasts, and risk management strategies.
Support implementation of effective software development processes and best practices.
Coordinate software development activities including requirements management, implementation, verification, validation, and release planning.
Ensure alignment between software, hardware, systems, and business deliverables.
Monitor project risks, dependencies, and resource constraints and drive timely resolution.
Facilitate project reviews and communicate status, key decisions, and risks to stakeholders and leadership.
Support compliance with design controls, software lifecycle processes, risk management practices, and regulatory requirements.
Contribute to continuous improvement initiatives that enhance product quality and development efficiency.
Required Qualifications
Bachelor's degree in Software Engineering, Engineering, Science, or a related technical discipline.
5+ years of experience in program management, project management, software engineering, systems engineering, quality engineering, or related technical roles.
Experience leading or supporting software development projects with cross-functional teams.
Understanding of software development lifecycles and project execution methodologies.
Experience managing project schedules, milestones, risks, dependencies, and stakeholder communications.
Strong organizational, communication, and problem-solving skills.
Demonstrated ability to collaborate effectively across technical and business functions.
Preferred Qualifications
Experience with Software as a Medical Device (SaMD).
Experience with connected medical devices, digital health platforms, mobile applications, cloud-based healthcare solutions, or remote patient management technologies.
Experience working in a regulated medical device or healthcare environment.
Familiarity with IEC 62304 (Medical Device Software – Software Life Cycle Processes), ISO 14971, FDA software guidance, cybersecurity requirements, and design control processes.
Experience supporting integrated hardware and software product development programs.
Experience with Agile, Scrum, SAFe, or hybrid software development methodologies.
Background in software engineering, systems engineering, design quality, or product development.
PMP, Agile, Scrum Master, or equivalent certifications.
Apply Now
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The base pay for this position is $114,000.00 – $228,000.00. In specific locations, the pay range may vary from the range posted.
