Sr. Software Engineer

• Design, develop, and maintain software functionality across integrated platforms
• Convert system behavior and features into clear, testable software requirements
• Create and maintain software design documentation and architecture artifacts
• Support verification activities, including test planning and requirements traceability
• Contribute to risk management efforts such as hazard analysis and failure assessments
• Ensure consistency between requirements, implementation, and verification results
• Collaborate with quality, testing, and cross-functional partners to support releases
• Identify documentation gaps and drive continuous improvement initiatives

• Coach and support fellow engineers on:

• Writing high-quality requirements
• Maintaining traceability
• Following compliant documentation practices

Participate in code reviews, design discussions, and complex debugging efforts

We are looking for a Senior Software Engineer who thrives at the intersection of hands-on development and regulatory rigor. This role is ideal for an experienced engineer who enjoys building and troubleshooting complex software while also taking ownership of technical documentation and development processes in a regulated environment.

Successful candidates see documentation as an essential part of delivering high-quality, reliable software-not as an afterthought-and are motivated to help raise the bar for consistency, traceability, and compliance across the engineering team. This position operates within established quality system and environmental, health, and safety guidelines., * 5+ years of professional software engineering experience

• Background working in medical device industry
• Strong experience with one or more of the following: C#, Python, JavaScript
• Proven success working on large, interconnected software systems
• Excellent analytical, debugging, and problem-solving skills
• Ability to clearly document technical designs and implementations
• Willingness to own both development and documentation responsibilities
• Strong communication skills and experience collaborating across teams

Preferred:

• Familiarity with industry standards such as IEC 62304, ISO 14971, or equivalent
• Experience with requirements management and traceability practices
• Exposure to software and risk documentation processes
• Involvement in verification planning and execution
• Experience supporting audits or regulatory reviews
• History of mentoring engineers or leading process improvements