Software Program Manager

This role is onsite at 5x per week.Position SummaryWe are seeking a motivated and detail-oriented Program Manager to support the development, deployment, and maintenance of software solutions for cutting-edge medical devices. The ideal candidate will collaborate with cross-functional teams to ensure project goals are met while adhering to regulatory requirements and quality standards in the medical device industry. This role provides an opportunity to contribute to life-saving technologies in a dynamic and innovative environment.ResponsibilitiesProgram Coordination and ManagementAssist Sr. Program Manager in planning, scheduling, and tracking product development projects from initiation to completion.Coordinate with software engineers, quality assurance teams, regulatory affairs, and other stakeholders.Maintain project timelines, milestones, and deliverables while ensuring alignment with overall product development goals.Documentation and ComplianceEnsure all project documentation complies with medical device regulations such as FDA 21 CFR Part 820, ISO 13485, ISO14971 and IEC 62304.Manage software requirements, design, risk management, and validation documents.Track and document changes to requirements, specifications, and project scope.Stakeholder CommunicationServe as a point of contact between engineering teams, product management, and external stakeholders.Prepare and present project updates, reports, and metrics to senior management.Facilitate team meetings and cross-functional collaboration.Risk and Issue ManagementIdentify, analyze, and mitigate project risks related to software development.Track and manage issues to resolution, ensuring minimal disruption to timelines.Quality and Process ImprovementSupport the implementation of Agile or hybrid project management methodologies tailored to the medical device industry.Participate in post-project reviews to identify areas for improvement and implement best practices.Support Regulatory SubmissionsCollaborate with regulatory and quality teams to provide necessary documentation and support for FDA, CE, or other global submissionsRequirementsBachelor's degree in computer science, Software Engineering, or a related field.1-3 years of experience in software project coordination or management, preferably in the healthcare or regulated industries.Familiarity with regulated environments (e.g., ISO, IEC standards and FDA guidelines)Skills:Strong organizational and time-management skills.Working knowledge of software development lifecycles (SDLC) and tools (e.g., Jira, Confluence, Git).Knowledge of Agile/Scrum or Waterfall methodologies.Excellent communication and interpersonal skills.Preferred Qualifications:Experience working with Product Marketing on user inputs and SW usability.Knowledge on software cloud access and cybersecurity, or equivalent are a plus.Salary Range- $132,000 - $166,000 (Annual Base Salary)

Created: 2025-02-19