Agile Program Lead / Principal Software Engineer

Suntra MedTech; Bedford (NH); Hybrid; USD 100,000 - 130,000; Full time

Job summary

A medical device development company in Bedford, NH is seeking an experienced Software Engineer to function as a Product Owner/Scrum Master. This role is pivotal in managing product backlogs and ensuring agile practices are followed, aligning with regulatory requirements in the medical sector. Candidates must possess a Bachelor's degree, with a minimum of 5 years' experience, including 2 years in product ownership or scrum roles. The position requires excellent communication skills and a strong understanding of Agile frameworks.

Qualifications

• 5+ years industry experience with 2+ years in product ownership or scrum mastery.
• Strong understanding of Agile/Scrum frameworks in regulated environments.
• Experience in medical device development.

Responsibilities

• Manage product backlog ensuring alignment with requirements.
• Facilitate agile ceremonies and coach teams on best practices.
• Act as primary liaison between technical teams and Program Manager.

Skills

Agile/Scrum frameworks

Technical communication

Regulatory compliance

Backlog management

Team coaching

Education

Bachelor's Degree

Job description

Description

We are seeking 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