Senior Software Engineer

Search Leaders, LLC•Minneapolis, MN

4d•$100,000 - $130,000

About The Position

This role combines advanced software engineering with compliance-driven development practices within a highly regulated medical device environment. The successful candidate will contribute to the design, implementation, verification, and documentation of software solutions while ensuring alignment with quality and regulatory requirements.

Requirements

5+ years of professional software engineering experience.
Experience working within regulated industries such as medical devices.
Strong proficiency in C#, Python, JavaScript, or similar programming languages.
Experience developing and supporting complex integrated software systems.
Demonstrated debugging, troubleshooting, and problem-solving capabilities.
Ability to create clear technical documentation from software implementations.
Experience balancing software development responsibilities with compliance documentation requirements.
Strong communication skills and ability to collaborate across multidisciplinary teams.

Nice To Haves

Familiarity with IEC 62304, ISO 14971, or related regulatory standards.
Experience with requirements management and traceability processes.
Knowledge of software design documentation including SDS and SAD deliverables.
Experience supporting risk management documentation and verification planning activities.
Exposure to audits, regulatory submissions, or quality system processes.
Experience mentoring engineers and driving process improvement initiatives.

Responsibilities

Design, develop, test, and support software features across the client's platform and related systems.
Translate software functionality into clear, testable, and maintainable requirements.
Create and maintain software design specifications and architecture documentation.
Develop verification plans, traceability artifacts, and supporting compliance documentation.
Participate in risk management activities including hazard analysis and FMEA exercises.
Ensure consistency between requirements, implementation, testing, and release documentation.
Collaborate with Quality Assurance and cross-functional stakeholders to support product releases.
Identify documentation gaps and implement process improvements across engineering workflows.
Mentor team members on requirements development, traceability, and documentation best practices.
Participate in code reviews, technical design discussions, and complex system debugging efforts.
Support adherence to quality system requirements and regulatory expectations.