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Director, Technical Service & Biomedical Engineering

Openwork
  • Cortlandt Manor, NEW YORK
  • $170,000–$180,000 Per Year
  • Quick Apply
10 days ago

Job Description

Director, Technical Service & Biomedical Engineering

The Director, Technical Service & Biomedical Engineering leads the strategic, operational, and regulatory direction of the companys 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 Clinical Technical Service, 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.

Responsibilities
  • Lead the strategic direction, daily operations, and performance of the Technical Support, Biomedical Engineering, and Installation functions.
  • Develop department goals, priorities, and operating plans aligned with broader business objectives.
  • Own budget planning, forecasting, expense management, and capital asset planning for the technical operations cost center.
  • Provide leadership for complex technical troubleshooting, escalation management, and resolution of hardware, software, and customer-related issues.
  • Support the evaluation, testing, and implementation of new instrumentation, analyzers, and related technical systems.
  • Partner cross-functionally with Clinical Technical Service, Marketing, Product Management, QA/Regulatory, and commercial teams to support product launches, validations, and training initiatives.
  • Develop and deliver technical training programs and materials for internal teams, distributors, and service partners.
  • Manage external service providers and ensure performance against service, quality, and compliance expectations.
  • Oversee the development and maintenance of SOPs, technical procedures, service documentation, and complaint-handling processes.
  • Monitor technical support data, quality control, and calibration trends to identify issues, improve reliability, and strengthen service performance.
  • Partner with Quality to align metrics, monitor KPIs, and maintain audit readiness across the function.
  • Drive continuous improvement initiatives that enhance operational efficiency, regulatory compliance, and customer satisfaction.

Qualifications:
  • Bachelors degree in engineering, biomedical engineering, a related technical field, or an equivalent combination of education and experience.
  • 10+ years of experience supporting laboratory equipment, instrumentation, analyzers, or related technical systems.
  • Leadership experience within the diagnostics, laboratory, or medical device industry.
  • Experience leading teams and driving improvement initiatives in a growing or evolving organization.
  • Strong background in technical troubleshooting, service operations, training, and regulated environments.

Preferred Qualifications:
  • Advanced degree in engineering, biomedical engineering, business, or related discipline.
  • Experience supporting capital equipment or complex diagnostic platforms in a customer-facing environment.
  • Familiarity with complaint handling, CAPA, validation activities, and service-related quality systems.
  • Experience working with distributors, third-party service providers, or global service networks.
  • Demonstrated success leading organizational change, process improvement, or service transformation initiatives.


Base salary range: $170,000 to $180,000 per year. This is the anticipated salary range for fully qualified candidates. The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry, education, etc.
 

Numbers & Facts

LocationCortlandt Manor, NEW YORK
Salary$170,000–$180,000 Per Year

Skills

  • Biomedical Engineeringunmatched
  • Budget Managementunmatched
  • Calibrationunmatched
  • Capital Equipmentunmatched
  • Capital Expenditure (CAPEX)unmatched
  • Clinical Laboratoryunmatched
  • Continuous Improvementunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Cost Controlunmatched
  • Cross-Functionalunmatched
  • Customer Relationsunmatched
  • Customer Satisfactionunmatched
  • Distribution Channelunmatched
  • Distribution Servicesunmatched
  • Documentationunmatched
  • Expense Managementunmatched
  • FDA (Food and Drug Administration)unmatched
  • Forecastingunmatched
  • ISO (International Organization for Standardization)unmatched
  • Identify Issuesunmatched
  • Instrumentationunmatched
  • Laboratoryunmatched
  • Laboratory Equipmentunmatched
  • Leadershipunmatched
  • Maintain Complianceunmatched
  • Medical Equipmentunmatched
  • Operational Strategyunmatched
  • Operationsunmatched
  • Operations Processesunmatched
  • Performance Managementunmatched
  • Performance Metricsunmatched
  • Process Improvementunmatched
  • Product Managementunmatched
  • Product Supportunmatched
  • Product Testingunmatched
  • Product/Service Launchunmatched
  • Quality Assuranceunmatched
  • Quality Controlunmatched
  • Quality Metricsunmatched
  • Regulationsunmatched
  • Regulatory Complianceunmatched
  • Regulatory Requirementsunmatched
  • Reliability Engineeringunmatched
  • Resolve Customer Issuesunmatched
  • Service Deliveryunmatched
  • Set Goalsunmatched
  • Standard Operating Procedures (SOP)unmatched
  • Strategic Planningunmatched
  • Team Lead/Managerunmatched
  • Technical Marketingunmatched
  • Technical Operationsunmatched
  • Technical Supportunmatched
  • Technical Trainingunmatched
  • Testingunmatched
  • Training Programunmatched
  • Trend Analysisunmatched

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