Suntra MedTech Solutions · 1 day ago
Agile Program Lead / Principal Software Engineer – Medical Device Development
Bedford,NH,US
Full-time
Hybrid
Senior Level, Lead/Staff
5+ years expSuntra MedTech Solutions is seeking an experienced software engineer to serve as a Product Owner / Scrum Master in the medical device development sector. This role will act as a bridge between technical development teams and the Program Manager, ensuring that agile practices are followed while meeting regulatory standards for medical devices.
Medical DeviceHealthcareManufacturingLife ScienceHealth Care
Responsibilities
Own and manage the product backlog, ensuring alignment with program milestones, regulatory requirements, and customer needs
Translate program-level requirements, system requirements, and user needs into clear, well-defined user stories and acceptance criteria
Prioritize backlog items based on risk, regulatory impact, value, and delivery timelines
Ensure traceability between user needs, system/software requirements, implementation, and verification activities
Serve as Scrum Master for one or more multi-disciplinary development teams
Facilitate agile ceremonies: backlog grooming, sprint planning, standups, sprint reviews, and retrospectives
Remove impediments and proactively manage dependencies across teams
Coach teams on agile best practices within a regulated development environment
Act as the primary liaison between the technical team and Program Manager
Ensure development work aligns with program schedules, deliverables, and risk management plans
Communicate progress, risks, and tradeoffs clearly to program leadership and stakeholders
Support cross-functional coordination with Quality, Regulatory Affairs, Clinical, and Cybersecurity teams
Ensure agile artifacts support design controls, including documentation, traceability, and verification planning
Work within ISO 13485, IEC 62304, IEC 62366, and FDA design control requirements
Partner with Quality and Regulatory teams to ensure backlog items and increments are audit-ready
Support cybersecurity, safety, and risk management activities as part of product development
Qualification
Required
Bachelor's Degree and 5+ years industry experience, with 2+ years in product ownership, scrum mastery, or technical program delivery
Hybrid environment but must be flexible and willing to work onsite for a minimum of 3 days per week
Experience working in medical device or other regulated product development environments
Strong understanding of Agile/Scrum frameworks and practical application in regulated settings
Ability to translate complex technical and regulatory requirements into actionable development work
Excellent communication skills across technical, quality, and executive stakeholders
Experience with development of software, firmware, or connected medical devices
Preferred
Familiarity with FDA submissions (510(k), De Novo, PMA) and design history files (DHF)
Knowledge of cybersecurity for medical devices and secure product development
Experience working closely with Program Managers on multi-disciplinary development programs
Certified Scrum Master (CSM), SAFe, or Product Owner certification
Company
Suntra MedTech Solutions
At Suntra MedTech Solutions™, we collaborate with visionary medtech leaders to turn pioneering thinking into tangible impact.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Drew Sunstein
Founder / Chairman of the Board
Recent News
2023-12-23
2023-12-23
Medical Design & Outsourcing
2023-12-23
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