Systems/Controls Engineer III

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Objective:  Support the post-acquisition integration of surgical device technologies by leading the transfer, verification, and archiving of system design documentation. This role will ensure technical continuity, regulatory compliance, and design history integrity across acquired assets and systems and will enable future system design changes for feature additions and design maintenance.

Key Responsibilities:

• Review and analyze legacy Class II medical device system documentation for acquired medical device technologies (e.g., system inputs, requirements, architecture, schematics, PCB layouts, wiring diagrams, BOMs, EOL tests and risk assessments).
• Lead and execute the transfer of design documentation from acquired companies into the company’s PLM (Product Lifecycle Management) and QMS (Quality Management System) platforms, including electrical / electronic and mechanical CAD design models and software projects.
• Ensure that Design History Files (DHFs) and Device Master Records (DMRs) for electrical systems are complete, compliant with IEC 60601-1, ISO 13485 (2016), FDA 21 CFR 820 and EU MDR, for the purpose of maintaining legal manufacturer status.
• Coordinate with cross-functional teams (RA/QA, Mechanical, Electrical, Software and Systems Engineering, Manufacturing) to validate that all design inputs and outputs are accounted for and properly documented.
• Collaborate with acquired company’s engineers (where available) to interpret undocumented or partially documented designs.
• Lead gap assessments and create remediation plans for missing or incomplete documentation.
• Provide technical insight into the safety and compliance status of legacy products

Qualifications / Training:

Required:

• B.S. or M.S. in Electrical Engineering or related discipline.
• 6+ years of experience in electrical systems design in the medical device industry.
• Strong understanding of medical device basic safety (IEC 60601-1), medical device design control (ISO 13485), risk management for medical devices (ISO 14971), and regulatory requirements for Class II electronic medical devices.
• Successful experience with design documentation, DHF/DMR structure, and post-market or acquisition integration work.
• Familiarity with tools such as Altium and OrCAD or equivalent ECAD and Aras PLM document control systems.
• Experience in assessing mechanical and software design packages.
• Excellent organizational skills and attention to detail.
• Strong communication and collaboration skills, especially in cross-functional or cross-company environments.
• Self-starting with a demonstrated capacity for both direct contribution and leadership

Preferred:

• 10+ years of experience in the medical device industry.
• Experience with standards compliance testing and verification.
• Background in post-merger technical integration or design transfer projects.
• Experience with legacy systems and reverse engineering documentation gaps.

This position may be available in the following location(s): US - St. Louis (Tree Court)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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Our Benefit Programs: Employee Benefits: Bausch + Lomb

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.