Systems Engineering
Our systems experts look across disciplines and consider multiple approaches and tradeoffs to architect an optimal solution to meet your priorities and constraints. The systems team then stays engaged to ensure the design implementation is consistent with the architected intent.
Our systems engineers apply their decades of MedTech development experience to:
- Architect and implement robust, maintainable, and extensible designs to support future features
- Define system and subsystem requirements and designs for medical devices
- Create fail-safe and fault-tolerant architectures for safety-critical solutions when lives depend on it
- Apply medical device risk management intelligently to meet your needs without going overboard
- Win praise from the FDA for providing clear and complete Design History Files (DHF) for our client’s submissions
- Medical device engineering and medical product development
Meet our Director of Systems Engineering
Nick Lesniewski-Laas
Nick brings over 10 years of experience solving difficult technical challenges by applying his deep expertise in microelectronics, electrical design, and software development.
Integrated Electromechanical Design
From initial concept to FDA submission and transfer to manufacturing, Sunrise supported every step of development, ensuring regulatory compliance and seamless integration of electromechanical design. This patented solution exemplifies Sunrise’s ability to tackle complex challenges and deliver groundbreaking medical technologies.
Transforming Point-of-Care Diagnostics
Sunrise Labs played a pivotal role in the development of a bench-top diagnostic platform, enabling laboratory-quality blood tests to be performed in minutes by untrained operators. The system’s architecture was designed to support a variety of test types and to meet the needs of both clinical and research applications. Sunrise’s innovative approach delivered a flexible development platform in just six months, meeting ambitious business and technical goals.
Strength through strategy
and transformation
Our agile project management is backed by years of experience across industry niches, revolutionary technologies, and organizations of all sizes.
Sunrise Labs doesn’t stop at the design stage. We are here to support your complete product life cycle.
Explore deeper insights on Systems Engineering
Check out our in-depth webinar recordings and articles to better understand our approach to systems engineering for medical product development.
Discover Our Full Range of Expertise
At Sunrise Labs, we specialize in Systems Engineering. But that’s just one part of the story. From concept development to clinical readiness, our expertise spans every stage of medical device development and life sciences innovation.