Gentuity, LLC · 1 day ago
Senior Program Manager
Sudbury, MA
Full-time
Onsite
Senior Level, Lead/Staff
$155K/yr - $175K/yr
8+ years expGentuity, LLC is 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.
Health CareManufacturingMedical Device
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
Qualification
Required
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
BS degree in engineering or technical field required
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
Company
Gentuity, LLC
Based in Sudbury, MA., Gentuity is a commercial-stage medical technology firm dedicated to developing next-generation intravascular imaging devices capitalizing on today’s best-in-class technologies.
51-200 employees
H1B Sponsorship
Gentuity, LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2020 (3)
Funding
Current Stage
Growth StageLeadership Team
David W. Kolstad
Chief Executive Officer
Christopher Petersen
Co-founder and Senior Vice President
Recent News
2025-09-09
Medical Product Outsourcing
2025-08-13
Company data provided by crunchbase