Systems/Controls Engineer II

Responsibilities

• Plan and execute full regression testing for the latest software releases, including authoring and maintaining test protocols and reports.
• Perform software verification and validation in accordance with the B+L Quality Management System (QMS), ensuring traceability to system and product requirements.
• Lead validation of service software in coordination with the service organization and cross-functional stakeholders.
• Transition third-party software documentation in-house; update and restructure key artifacts (e.g., Software Requirements Specification (SRS), Software Design Specification (SDS), Software Architecture Description (SAD)) to support ongoing development and maintenance.
• Author and maintain software documentation aligned to the appropriate Level of Concern (per IEC 62304 and FDA guidance); address gaps identified during Design History File (DHF) remediation efforts.
• Support the Software Field Upgrade Procedure, including documentation development, validation activities, execution of dry runs, and release readiness.
• Provide software support to the external probe manufacturer, including maintainance of associated requirements, design, and test documentation.
• Contribute to product cybersecurity activities, including threat modeling, security risk assessments, and development/maintenance of cybersecurity documentation.
• Support integration of software requirements into the B+L QMS (including traceability matrices) and harmonize software-related hazards across risk management files.
• Apply relevant industry standards and regulatory requirements across all deliverables.
• Maintain the software V&V plan and coordinate with test engineers, software engineers, and external suppliers to ensure timely execution and documentation
• Support post-submission DHF remediation activities related to software.

Qualifications

• Bachelor's degree in Engineering (Computer, Software, Systems, Biomedical, or Electrical), Computer Science, or equivalent experience
• 3–7 years of engineering experience, with a strong emphasis on software
• Demonstrated ability to interpret, develop, and review software requirements, design, and test documentation
• Strong communication and organizational skills
• Self-motivated with the ability to work independently and manage multiple priorities