The Principal Software Development Engineer provides expertise in the design, development, characterization, and testing of complex pllication software used to drive and manage complex electromechanical medical devices. In this role you will interface with a strong multidisciplinary team across the full product development life cycle including requirements, risk, implementation and testing activities.
ROLE OVERVIEW
- Design and develop application software following company and industry requirements and best practices
- Assist in development of software subsystem architectures aligned to product level requirements and architectures including software requirements definitions and sub-system designs
- Collaboratively work with other engineering groups to translate system level requirements into product architectures making tradeoff decisions regarding hardware and software partitioning
- Performs advanced risk analyses using FMEA and fault tree methods. Works with other engineering disciplines to develop, implement, and verify solutions
- Perform software verification including code reviews, writing unit test cases, and running static analysis
- Document system design inputs and outputs using the design control and document management system
- Evaluates product performance on an on-going basis and initiates and evaluates required changes to the designs to improve and optimize performance
- Solve complex software issues by analyzing critical factors and recommending corrective or alternative actions
- Ensures adherence to company quality system, product specifications, industry standards, and quality and regulatory procedures and requirements
- Maintains accurate documentation of concepts, designs, drawings, and processes through lab notebooks or other methods
EXPERIENCE
- Bachelor’s Degree in Software or Electrical Engineering. Master’s degree preferred.
- 5+ years Software Engineering experience in the design and development of complex, software driven electromechanical Class II medical devices; Class III experience preferred
- Professional experience with .NET development platform - specifically C#, WPF, and/or MAUI
- Experience with C#/C++ multi-threading
- Experience with Qt/QML based GUI development is desirable
- Experience with automated GUI testing is desirable
- Experience with the design and implementation of performant GUIs for imaging centric applications is desirable
- Prior experience with cloud integration with a focus on IoT type functionality is desirable
- Detailed knowledge of key regulatory requirements included ISO 13485, ISO 14971, ISO 62304 as well as FDA QSR 21 CFR Part 820 desirable
- Experience with electronic design control and document management systems preferred
- Ability to work independently with high competency and little guidance.
- Must be a creative problem solver that can think outside of the box to develop novel solutions to complex problems
- Must be able to work in a fast paced, high energy, collaborative team that possesses a strong sense of urgency
- Strong communication skills
- Strong analytical and problem solving skills