Principal Software Engineer - Medical Devices

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 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.

Requirements

• 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 instrument 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 and programming languages including JAVA and one of the following: C/C++, or C#. Skills in in C#.net (8) highly preferred
• 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 (CVS, SVN, PerForce), issue tracking (Mantis, Jira), requirements management (DOORS), code review tools (Code Collaborator, Crucible) and 3rd party project build tools
• Demonstrated leadership skills
• Creative / innovative, able to think on your feet and work well given typical project schedules
• Good organizational and multi-tasking skills
• MS Project skills a plus
• Software time and cost estimation experience a plus
• Experience as SW Team Leader is required
• Experience working directly with customers