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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
- Scrum Master & Agile Execution
- Program & Stakeholder Interface
- Regulatory & Quality Alignment
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 three (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
