Agile Program Lead / Principal Software Engineer (Medical Device Development)

TL;DR

Agile Program Lead / Principal Software Engineer (Medical Device Development): Serve as Product Owner and Scrum Master connecting multi-disciplinary technical teams with Program Manager, managing product backlog and agile execution while ensuring compliance with medical device regulations. Focus on translating program requirements into user stories, facilitating agile ceremonies, and maintaining traceability for ISO 13485, IEC 62304, and FDA standards.

Location: Hybrid remote in Bedford, NH – must work onsite for a minimum of 3 days per week

Company

hirify.global is a medical device development company focused on regulated product delivery.

What you will do

• Own and manage product backlog, translating requirements into user stories with acceptance criteria and prioritization based on risk, value, and timelines
• Serve as Scrum Master for multi-disciplinary teams, facilitating ceremonies like sprint planning, standups, reviews, and retrospectives
• Remove impediments, manage dependencies, and coach teams on agile practices in regulated environments
• Liaise between technical teams and Program Manager, communicating progress, risks, and aligning with schedules
• Ensure agile artifacts support design controls, traceability, and regulatory requirements including cybersecurity and risk management

Requirements

• 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 in Bedford, NH
• Experience in medical device or regulated product development environments
• Strong understanding of Agile/Scrum in regulated settings and ability to translate complex technical/regulatory requirements
• Excellent communication across technical, quality, and executive stakeholders
• Experience with software, firmware, or connected medical device development

Nice to have

• Familiarity with FDA submissions (510(k), De Novo, PMA) and design history files (DHF)
• Knowledge of cybersecurity for medical devices
• Experience working with Program Managers on multi-disciplinary programs
• Certified Scrum Master (CSM), SAFe, or Product Owner certification