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Senior Project Manager

$68.98 - $73.98 per hour

Cynet Systems

Job TitlePay Range: $68.98hr - $73.98hrRequirements/Must HaveBachelor’s degree in engineering, Computer Science, or related technical discipline.Minimum 5 years of hands-on software development experience with C# and WPF.10-15 years of experience in software project management within software driven medical devices or other regulated industries.Demonstrated experience leading cross functional software development programs.Strong understanding of regulated software development lifecycles and quality systems.Proven ability to manage complex, ambiguous programs with multiple stakeholders.Ability to plan and execute software projects in the medical device industry.Working knowledge of the software development lifecycle (SDLC) in a regulated environment, with exposure to agile or hybrid delivery models.Proficiency with project management and software delivery tools (e.g., MS Project, JIRA), including development of WBS, schedules, and dependency tracking.Working understanding of software day to day challenges and system level integration.Strong verbal and written communication skills, with the ability to collaborate across Software, Systems, Quality, and Regulatory teams.ResponsibilitiesLeading the planning and execution of complex software development and integration software.Partnering closely with R&D, Quality, Regulatory, IT, Cybersecurity, Clinical, Operations and other cross-functional teams to develop software solution into the medical device portfolio.Develop and maintain plans covering software development, verification/validation, cybersecurity, and regulatory deliverables.Manage program schedules, budgets, resources, risks, and interdependencies across multiple cross functional teams.Provide clear, data driven program status, risks, and decision points to R&D leadership.Drive alignment between legacy and acquired development processes, tools, architectures, and documentation.Work closely with software engineering teams to ensure development and integration activities comply with applicable standards.Ensure proper integration of software lifecycle artifacts, including requirements, architecture, risk management, verification, validation, and cybersecurity documentation.Support design reviews, phase gate reviews, and regulatory submissions related to integrated software products.Facilitate alignment on system architectures, interfaces, data flows, and platform strategies across organizations.Drive issue resolution and decision making across organizational boundaries.Track software project progress and provide transparent communication and interfaces with all areas affected by the project.Conduct retrospectives, and lessons learned, and implement process improvement initiatives to drive future success.Additional duties, as assigned.Nice to HaveWeb technology experience (2 years preferred).Familiarity with FDA, EU MDR, and global regulatory expectations for software enabled medical devices.Experience with cybersecurity, cloud connected devices.PMP, PgMP, Agile, or SAFe certification.Master’s degree in Engineering, Management, or related field.Experience in medical device software, including new product development and sustaining software.SkillsC#.WPF.Software Project Management.SDLC.Agile.MS Project.JIRA.WBS.Cybersecurity.Medical Device Software.Qualification And EducationBachelor’s degree in engineering, Computer Science, or related technical discipline.10-15 years of experience in software project management within regulated industries.

Vacancy posted 1 day ago
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