Software Project Manager
About the role
The Software Project Manager II supports complex software projects in a regulated medical device environment, focusing on project coordination, execution, documentation management, and administrative project management activities.
Responsibilities
- Drive software and product development projects from concept through regulatory filing and commercialization within a regulated medical device environment.
- Create, maintain, and update detailed project plans, timelines, and schedules across multiple concurrent software and product release workstreams.
- Manage documentation trackers, RAID logs, risk registers, release plans, and change order workflows to ensure accurate and up-to-date project information.
- Prepare and maintain meeting agendas, document action items, track task status, and follow up with stakeholders to ensure timely completion of deliverables.
- Cook up cross-functional project activities with software development, testing, quality, regulatory affairs, product, medical/clinical, commercial, and operations teams.
- Align projects with established product development frameworks, standard operating procedures (SOPs), and documentation and change control processes.
- Maintain project progress, identify risks and issues, assess schedule and scope impacts, and proactively escalate concerns or propose mitigation strategies.
- Support agile software delivery practices and ensure project execution remains documentation-heavy and compliant with regulated environment requirements.
- Coordinate and facilitate project meetings, ensuring clear communication of objectives, decisions, and next steps to all stakeholders.
- Provide regular project status updates to stakeholders, summarizing progress, risks, dependencies, and upcoming milestones.
- Contribute to continuous improvement of project management processes, tools, and templates to enhance efficiency and consistency.
Essential Skills
- 3–5 years of project management experience supporting complex software, technical, or product development projects.
- Proven ability to manage project plans, documentation trackers, RAID logs, timelines, action items, and stakeholder follow-up with limited supervision.
- Strong Smartsheet experience and proficiency with MS Office and project management tools.
- Strong verbal and written communication skills, with the ability to communicate clearly with cross-functional stakeholders.
- Excellent organizational skills and the ability to manage multiple priorities and concurrent workstreams in a fast-paced environment.
- Demonstrated ability to maintain project plans, documentation trackers, RAID logs, and task status updates accurately and consistently.
- Experience coordinating meetings, documenting action items, and following up on deliverables to closure.
- Able to assess risks and issues, understand schedule impacts, and escalate or propose solutions where appropriate.
- Bachelor’s degree.
- Comfort with hands-on project coordination, documentation management, administrative project management activities, and follow-up work.
Additional Skills & Qualifications
- Experience working within a regulated medical device environment or other regulated industry is strongly preferred.
- Experience with Jira and Confluence for software development and project tracking is a plus.
- Familiarity with document control processes and systems is beneficial.
- Experience with change orders and change control workflows is advantageous.
- Exposure to commercial software product development and release processes is a plus.
- Experience supporting agile software delivery environments is helpful.
- Ability to collaborate effectively with software development, testing, quality, regulatory, product, medical/clinical, and commercial teams.
- Interest in full product lifecycle activities from concept through regulatory filing and commercialization.
Work Environment
This is a fully remote project management role supporting software and cloud-based product initiatives in a regulated medical device environment. Candidates may work from anywhere in the U.S., provided they maintain sufficient overlap with Pacific Time working hours. The schedule follows standard business hours, approximately 9 AM–5 PM, 40 hours per week, with the possibility of occasional overtime based on project needs. The work environment is high-volume and fast-paced, involving multiple concurrent product releases, extensive project documentation, change order processing, risk tracking, schedule management, and meeting coordination. The role requires frequent cross-functional collaboration with Software Development, Testing, Quality Assurance, Regulatory Assurance, Product, Medical/Clinical, and Commercial teams. No travel is required, and work is performed using remote collaboration and project management tools such as Smartsheet, MS Office, Jira, Confluence, and other documentation and tracking systems.