Project Manager (Software)

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Requirements:

• Bachelor's degree in Information Technology, Software Engineering, Computer Science, or related field
• Minimum 5 years of software product development experience in a regulated industry
• Minimum 5 years of project management experience with demonstrable success
• Proven track record of successfully transitioning projects to manufacturing
• Expert-level understanding of Agile project management methodologies
• Proficiency in project management tools (JIRA, GitHub, etc.)
• Strong understanding of software development life cycle (SDLC)
• Experience with Phase Gate Design Process
• Knowledge of regulatory requirements in medical device software development

Responsibilities:

• Lead and manage 1-3 concurrent software development projects from inception to completion
• Develop and maintain comprehensive project plans, including resource allocation, timelines, and budgets
• Create and monitor risk management strategies, including identification, documentation, and mitigation plans
• Chair and facilitate design reviews, development status meetings, and cross-functional project reviews
• Oversee verification and validation processes to ensure compliance with industry regulations
• Establish and maintain detailed design documentation systems and requirements specifications
• Ensure proper documentation of design reviews, risk analyses, and validation reports
• Maintain complete and accurate design history files
• Lead sprint planning sessions and daily stand-ups to ensure team alignment
• Monitor sprint velocities and team performance metrics
• Guide development teams in breaking down complex features into manageable user stories
• Champion Agile methodologies and best practices across the organization
• Facilitate sprint retrospectives and continuous improvement initiatives
• Collaborate with manufacturing teams for smooth development-to-production transition
• Coordinate the creation of manufacturing documentation and training materials
• Work with quality assurance teams on production validation
• Support post-launch monitoring and improvement initiatives
• Mentor team members in project management methodologies
• Drive team accountability while fostering innovation
• Maintain traceability between requirements, design elements, and test cases