Job Description

SUMMARY:

We are seeking a strategic, hands-on Senior Program Manager with a strong emphasis on software-enabled solutions to lead cross-functional teams in delivering innovative medical device products. This role will drive execution throughout the product development lifecycle, ensuring on-time delivery, product quality, cost targets, and resource allocation while maintaining full compliance with global regulatory requirements.

The ideal candidate will bring deep expertise in project management, particularly in launching software products within regulated medical device environments, and will actively support the software development team, including Scrum Master.

KEY RESPONSIBILITIES:

• Lead cross-functional teams (R&D, QA/RA, Clinical, Marketing, Operations) to deliver new product initiatives from concept to commercialization.
• Own and manage detailed project schedules. Partner with functional leaders to provide input to, and help manage, program-related budgets and resource plans to ensure timely delivery.
• Act as a Scrum Master for software development teams, driving sprint planning, backlog refinement, daily scrum, and facilitating effective retrospectives.
• Ensure all design control deliverables are completed per SOPs and regulatory standards.
• Collaborate with software engineers, systems engineers, and product managers to align technical execution with business goals.
• Identify and mitigate program risks, escalate issues, and drive resolution across stakeholder groups.
• Create, align, and provide regular project updates (written and verbal) to appropriate stakeholders and relevant management board; create presentations, dashboards, and executive summaries – both scheduled and ad-hoc.
• Accountable for Design History File (DHF) readiness and availability for internal and external, scheduled, and unscheduled audits. Participate in audits as required.
• Lead the Core Team in the development of a program charter, objectives, program plan and schedule for assigned program.
• Build team ownership and commitment to project and business plans and define program milestones, deliverables, and associated resource requirements.
• Proactively assess program health and identify opportunities for program change; implement and manage changes and interventions to achieve timely program outputs.
• Proactively manage program-related actions and deliverables, holding team members and functional manager accountable for completion.
• Conduct highly effective cross-functional team meetings to ensure accountability and milestone achievements; create agendas and publish minutes/actions.
• Proactively manage performance issues and conflicts within project team; work to resolve these issues in alignment with functional management.
• Provide input to functional leaders on team member performance and functional management support.
• Cultivate a team culture of continuous improvement and teamwork that strives to improve quality, safety, delivery, and cost.
• Actively build and foster collaborative relationships across all levels to improve overall outcomes and timely program execution.

EXPERIENCE/SKILL REQUIREMENTS:

• 8+ years of experience in medical device program management, with 3+ years focused on software product launches.
• 6+ years demonstrated experience in managing large, technically complex, new product development programs.
• Must be able to work independently and be self-motivated with a strong sense of urgency and drive for results.
• Excellent verbal and written communication skills. Comfortable and adaptable presenting to different audiences and levels of the organization – including executive management teams.
• Strong understanding of Agile/Scrum methodologies and experience acting as Scrum Master.
• Familiarity with IEC 62304, and cybersecurity standards (e.g., FDA guidance).
• Excellent leadership and stakeholder management skills.
• Master-level user of MS Project and Jira; expertly proficient in Excel, PowerPoint, Visio, Word

PREFERRED

• Ability to work in an environment with competing priorities. Highly effective at dealing with change and ambiguity as business needs shift, responding well under pressure, and demonstrating flexibility while ensuring compliance.
• Formal training in program management completed; PMP certification preferred; Six Sigma; Scrum Master Certification and/or Agile PMP certification preferred.
• Ability to expertly analyze complex problems, interpret operational needs, develop integrated, creative solutions – and implement these solutions.
• Experience with and/or training in change management.

EDUCATIONAL REQUIREMENTS:

• BS degree in engineering or technical field required; MS or MBA preferred.

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