Systems/Controls Engineer II

Bausch + Lomb•US-MO-Saint Louis Kirkwood, MO

3d•Onsite

About The Position

The candidate will serve as a software-focused Systems Engineer supporting a medical device program through post-submission activities. This role partners with the systems team and engineering subject matter experts (SMEs) and is responsible for software verification and validation (V&V), service software validation, and remediation of third-party software documentation. Key responsibilities include supporting external suppliers, contributing to cybersecurity activities, and ensuring compliance with regulatory and quality requirements. The role requires strong organizational skills, the ability to manage multiple concurrent assignments, and a high degree of independence.

Requirements

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
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Nice To Haves

Experience in the medical device industry, including software V&V, regression testing, and development of software documentation (SRS, SDS, SAD, test protocols and reports)
Working knowledge of relevant standards and regulations, including IEC 62304, ISO 14971, IEC 62366, FDA premarket software guidance, 21 CFR Part 11, and EU MDR
Familiarity with medical device cybersecurity practices
Experience remediating or internalizing third-party software documentation
Experience with scripting or test automation and ability to read source code (e.g., C/C++, C#, Python)
Familiarity with tools such as MS Office, Aras PLM, and D2

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.