Director of Field Service Engineering at POLYMEDCO, INC – Cortlandt, New York
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About This Position
Position Overview:
The Director of Field Service Engineering is responsible for leading the strategic, operational, and regulatory functions of the Biomedical Engineering department to ensure alignment with organizational goals. This role provides direct leadership to all Biomedical Engineering staff, driving performance, accountability, and professional development across teams. The position oversees budget planning and cost center management, provides advanced technical expertise for instrumentation and test systems, and leads troubleshooting and resolution of complex hardware, software, and customer-related issues.
Working cross-functionally with Clinical Technical Service, Marketing, Product Management, QA/Regulatory, and commercial teams, the Technical Operations Manager supports new product validations, training initiatives, and quality compliance. The role ensures adherence to FDA, ISO 13485, Canadian Medical Device regulations, Joint Commission standards, and other applicable laboratory and regulatory requirements while developing and maintaining SOPs, audit processes, and quality systems. Additionally, this position manages contracted service providers, oversees documentation within technical support systems, evaluates QC and calibration data, and drives continuous improvement initiatives to enhance operational efficiency, regulatory compliance, and customer satisfaction.
Key Responsibilities:
- Strategic Planning: Develop and implement strategic plans for the department in conjunction with VP, ensuring alignment with organizational goals and objectives.
- Budget Management: Develop and manage budgets for technical operations cost center, including forecasting, expense tracking and capital assess planning and ensure budget adherence.
- Leads all Biomedical Engineering staff and support all functions of troubleshooting and service.
- Provide technical support for the instrumentation and equipment according to established protocol.
- Assist in evaluation, diagnosing, and resolution of higher level customer complaints.
- Troubleshoot both hardware and software related problems on equipment and analyzers.
- Lead higher level troubleshooting technical training for engineering counterparts for distributors and service companies. Develop training material and serve as a resource in instrument operation and maintenance.
- Work on new test systems and make recommendations regarding technical procedures. Perform evaluation of new equipment. Assist in developing and writing test procedures and Standard Operations Protocol.
- Manage and oversee the contracted service providers ensuring they are meeting their commitments.
- Collaborate with Quality team to ensure metrics are aligned with leadership drive KPIs.
- Initiate, maintain and complete all necessary documentation in the Technical Support Software System (CQ). Develop, evaluate and assist with interpretation of data for the purpose of account correlation and troubleshooting.
- Ensure compliance with internal policies listed in Employee Handbook, internal department processes and all SOP’s
- Perform internal quality auditing as needed.
- Develop procedures and SOPs for parts management, complaint handling, equipment maintenance, staff and customer training, communication with partners, as well as other activities.
- Demonstrate knowledge of Laboratory Regulatory Agencies and policies, applicable FDA regulations, ISO 13485:2003 standards and Canadian Medical Device regulations.
- Ensure compliance with relevant regulations, guidelines, and standards, such as the Joint Commission and FDA.
Key Requirements:
- Travel up to 25%
- Occasional off hours work
- Ability to train and guide others.
- Must have knowledge of a variety of computer software applications in word processing, spreadsheets, database and presentation software, i.e., Power Point, Excel, Visio, and Microsoft Outlook and Internet.
Required Experience:
- Previous experience in the diagnostics or medical devices industry.
- Experience working in a fast-growing company and driving transformation
- Minimum of bachelor’s degree or a combination of education, training and/or 10 years experience in a related field
- Minimum 10 years experience on laboratory equipment and instruments or other related equipment.
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Job Location
Job Location
This job is located in the Cortlandt, New York, 10567, United States region.