Principal Software Engineer - Medical Devices

Job Summary:
Are you a strong Principal Software Engineer who collaborates with other high-quality, dedicated engineering professionals? Looking for purpose? You would have the opportunity to develop cutting edge Medical Device products that are used every day to improve people’s health and well-being.
This opportunity requires a driven engineer willing and able to tackle complex and challenging technical issues using their expertise and ingenuity. You will enjoy a culture that values hard work, creativity, and getting the job done; will work side by side with other dedicated engineers across a range of disciplines; and will know that the products that they take to market will ultimately make real improvements in people’s lives.

Responsibilities:

Design, implement, and deliver reliable, high-quality, robust embedded and desktop software targeted to complex medical instruments meeting regulatory standards.
Create, maintain, and review software project documents, including software development plans, software configuration plans, and detailed software design documents.
Participate in software project risk analysis and hazard analysis.
Drive software requirements with other members of the software team as appropriate (team lead, architect, etc.) and proactively work to integrate with system requirements.
Participate in Software Change Control Boards and participate in the investigation and resolution of software defects.
Utilize software engineering best practices (e.g., unit testing, integration testing, static analysis, code reviews, design reviews, Doxygen documentation)
Develop software within the Continuous Improvement development process.
Improve Continuous Improvement process (recommend process improvements, software tools, and helper scripts)
Work cooperatively within the software group as well as across disciplines such as systems, electrical, optical, and mechanical to deliver projects on time and on budget.

Qualifications:

Bachelor’s degree in computer science, Electrical Engineering, Mathematics, or related discipline (master’s degree preferred)
10 or more years of relevant experience developing software for complex instruments or devices that include motion control and fluidics
Demonstrated experience in object-oriented design methodology and programming languages, primarily C# and C++
Understanding of revision control systems and issue tracking systems
Ability to work independently or in a team environment
Strong oral and written communication skills
Able to work on multiple projects simultaneously (Good organizational and multi-tasking skills)
Demonstrated experience in software development lifecycle (Agile, Spiral), object-oriented design methodology.
Design experience of software for hardware instruments/devices that include motion control interfaces
Experience with medical device regulatory standards such as 21 CFR Part 820, IEC 62304, and ISO 13485, including experience with system risk/hazard analysis
Experience with software configuration tools for source code control issue tracking (Azure DevOps/Git)
Demonstrated leadership skills
Creative/innovative, able to think on your feet and work well given typical project schedules
Good organizational and multi-tasking skills
Software time and cost estimation experience is a plus
Experience as a SW Team Leader is required
Experience working directly with customers
Experience with AI tools and their integration with software development.

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