At Suntra we take products from concept to market, with a portfolio spanning life-sustaining pumps, surgical robots, and guidance systems, in-vitro and in-vivo diagnostic devices, 3D imaging systems, insulin and infusion pumps, wearable monitors with connectivity to mobile apps and cloud databases/web interfaces, and much more.
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
We’re Looking For:
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
Why work with us:
- A comprehensive benefits package including Health Insurance with 100% company-paid Dental, Life and Disability insurance
- Three weeks’ vacation, unlimited sick time, plus 10 paid holidays
- Monthly lunches and socials, “Bagel Tuesday”
- Work-from-home flexibility
At Suntra MedTech Solutions, we’re driven by a simple but powerful idea: to make a measurable difference in patients’ lives by partnering with medtech companies to bring life-changing technologies to market. Formerly known as Sunrise Labs, we’ve spent over 30 years building a reputation for excellence. Now, as Suntra, we’re expanding that legacy with a broader, more integrated approach.
Our teams work at the intersection of consulting, engineering, and innovation, helping clients solve complex challenges from the earliest spark of an idea through to commercial readiness. Whether we’re uncovering strategic gaps, scaling an established pipeline, or designing with patients and providers in mind, we do it with rigor, heart, and purpose.
If you want to work where your expertise is valued, your curiosity is encouraged, and your work has real-world impact, Suntra is the place to grow. We’re building the future of medtech—come help us lead it.
We’re in southern New Hampshire where the mountains, lakes, and oceans are our playground, and Boston is just down the road. We offer great benefits and competitive salaries based on experience.
We do not accept resumes from staffing agencies or search firms unless a valid search agreement is in place with the agency for a specific position.
