Manager of Engineering - Electrical

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.

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

• 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