Agile Program Lead / Principal Software Engineer – Medical Device Development

Description

 We are accepting resumes for an experienced software engineer operating as a Product Owner / Scrum Master to serve as the connective tissue between technical development teams (software, firmware, systems, cybersecurity, electronics, mechanical, test) and the Program Manager responsible for overall product delivery. This role ensures that requirements are clearly defined, prioritized, and executed using agile practices—while maintaining compliance with medical device regulatory standards.

The ideal candidate understands both agile product delivery and regulated medical device development and can enable the team to benefit from an agile development process while ensuring that program-level objectives are met.

Responsibilities

Product Ownership & Backlog Management

• 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

Scrum Master & Agile Execution

• 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

Program & Stakeholder Interface

• 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

Regulatory & Quality Alignment

• 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

Requirements

Required Qualifications

• 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 Qualifications

• 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