**This position is on-site in Cortlandt Manor, NY; relocation not available**
The Director, Technical Service & Biomedical Engineering leads the strategic, operational, and regulatory direction of the company’s technical service and biomedical engineering functions. This role is responsible for building and developing high-performing teams across Technical Support, Biomedical Engineering, and Installation while ensuring exceptional service delivery, technical excellence, and regulatory compliance. The position also oversees budget planning, cost center management, technical troubleshooting, service partner performance, and continuous improvement initiatives that enhance customer satisfaction and operational effectiveness.
Working cross-functionally with Marketing, Product Management, QA/Regulatory, and commercial teams, this leader plays a critical role in supporting product validations, training initiatives, complaint resolution, and quality system compliance. The role ensures adherence to FDA, ISO 13485, Canadian Medical Device regulations, Joint Commission standards, and other applicable laboratory and regulatory requirements while driving strong documentation practices, audit readiness, and process improvement.
Key Responsibilities:
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Lead the strategic direction, daily operations, and performance of the Technical Support, Biomedical Engineering, and Installation functions.
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Develop department goals, priorities, and operating plans aligned with broader business objectives.
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Own budget planning, forecasting, expense management, and capital asset planning for the technical operations cost center.
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Provide leadership for complex technical troubleshooting, escalation management, and resolution of hardware, software, and customer-related issues.
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Support the evaluation, testing, and implementation of new instrumentation, analyzers, and related technical systems.
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Partner cross-functionally with Marketing, Product Management, QA/Regulatory, and commercial teams to support product launches, validations, and training initiatives.
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Develop and deliver technical training programs and materials for internal teams, distributors, and service partners.
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Manage external service providers and ensure performance against service, quality, and compliance expectations.
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Oversee the development and maintenance of SOPs, technical procedures, service documentation, and complaint-handling processes.
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Monitor technical support data, quality control, and calibration trends to identify issues, improve reliability, and strengthen service performance.
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Partner with Quality to align metrics, monitor KPIs, and maintain audit readiness across the function.
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Drive continuous improvement initiatives that enhance operational efficiency, regulatory compliance, and customer satisfaction.
Key Requirements:
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Ability to lead, coach, and develop technical teams in a fast-paced, growth-oriented environment.
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Strong communication and collaboration skills, with the ability to work effectively across functions and with external partners.
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Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Visio, Outlook, and internet-based systems.
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Willingness to travel up to 25% and work occasional off-hours as needed.
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Demonstrated knowledge of applicable regulatory and quality standards within diagnostics, laboratory, or medical device environments.
Required Experience:
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Bachelor’s degree in engineering, biomedical engineering, a related technical field, or an equivalent combination of education and experience.
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10+ years of experience supporting laboratory equipment, instrumentation, analyzers, or related technical systems.
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Leadership experience within the diagnostics, laboratory, or medical device industry.
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Experience leading teams and driving improvement initiatives in a growing or evolving organization.
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Strong background in technical troubleshooting, service operations, training, and regulated environments.
Preferred Qualifications:
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Advanced degree in engineering, biomedical engineering, business, or a related discipline.
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Experience supporting capital equipment or complex diagnostic platforms in a customer-facing environment.
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Familiarity with complaint handling, CAPA, validation activities, and service-related quality systems.
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Experience working with distributors, third-party service providers, or global service networks.
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Demonstrated success leading organizational change, process improvement, or service transformation initiatives.
