Medical Device Embedded System Engineer Jobs in Ohio

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:  
We are seeking a highly experienced and technically proficient Senior Manager to lead our Electronics Design Group within a surgical equipment R&D organization. This role is responsible for overseeing the design, development, and verification of electronic systems for Class II and III medical devices, responsible for the quality and manufacturability of the PCB and cable designs, regulatory compliance and high-quality execution across multiple programs.  The ideal candidate has a strong background in electronics design, electronics systems engineering, and team leadership, along with a thorough understanding of IEC 60601 standards, FDA and EU design control regulations, and risk management practices. 

Responsibilities:

• Lead and mentor a multidisciplinary team of electrical engineers, designers and technicians
• Maintain existing portfolio of 50+ mixed-signal PCBs, including cable interconnections
• Drive the architecture, design, and implementation of electronics hardware for complex electromechanical and embedded medical device in emerging designs
• Provide estimates of design project resource and time requirements and design path risks to NPD project managers
• Oversee all phases of the product development lifecycle (from concept through commercialization) ensuring timely delivery and compliance with regulatory standards.
• Collaborate cross-functionally with software, mechanical, systems, quality, and internal and external manufacturing teams.
• Ensure compliance with relevant standards (e.g., IEC 60601, ISO 13485, ISO 14971, IEC 62304).
• Define and maintain electronics development best practices, tools, design reviews, and documentation.
• Provide technical leadership in areas including analog/digital design, power management, sensors, wireless communication, and embedded systems.
• Coordinate with external partners, suppliers, and contract manufacturers when needed.
• Support regulatory submissions (e.g., FDA 510(k), PMA) and audits as the technical electronics subject matter expert.
• Participate in long-term strategy and resource planning for the electronics function.
• Establish and track key performance metrics for engineering deliverables and team development.

Qualifications / Training:

Required:

• B.S. or M.S. in Electrical Engineering or related discipline.
• 7-10+ years of experience in electrical systems design in the medical device industry.
• Technical competence in digital, analog and mixed signal areas.
• Understanding of both rapid prototyping and production PCB processes
• 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, with the ability to clearly and quickly communicate relevant technical issues to non-technical management peers.
• Self-starting with a demonstrated capacity for both direct contribution and leadership

Preferred:

• 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
  

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