Director of Biomedical Engineering
Location: Cortlandt Manor, NY
Job Type: Direct Hire
Company: Openwork
Salary: 0
Category: Engineer
Job Description Apply Now
The Director of Biomedical Engineering oversees the strategic, operational, and regulatory leadership of technical service and biomedical engineering operations within the organization. This Director of Biomedical Engineering position is responsible for the comprehensive management of teams specializing in technical support, biomedical engineering, and equipment installation. The Director of Biomedical Engineering ensures the highest standards of service delivery, technical expertise, and regulatory compliance across all technical operations. Additionally, this role manages budget planning, cost center operations, technical troubleshooting efforts, and the ongoing improvement of workflows to maximize customer satisfaction and organizational effectiveness.
In this Director of Biomedical Engineering position, you will work collaboratively with cross-functional departments including clinical technical service, marketing, product management, quality assurance, regulatory affairs, and commercial teams. The Director of Biomedical Engineering plays a key role in supporting product validations, technical training initiatives, complaint resolution, and quality system compliance, ensuring adherence to strict industry and regulatory standards such as FDA, ISO 13485, Canadian Medical Device regulations, Joint Commission standards, and other relevant laboratory requirements. This role is critical in maintaining robust documentation practices, audit readiness, and ongoing process improvement.
Director of Biomedical Engineering - Summary- Lead all aspects of technical service and biomedical engineering operations, ensuring alignment with company goals and regulatory requirements.
- Supervise and develop high-performing teams in technical support, engineering, and installation.
- Drive continuous improvement in service quality, process efficiency, and customer satisfaction.
- Maintain a culture of compliance with all applicable regulatory standards and internal policies.
- Direct the daily operations and strategic planning of technical support, biomedical engineering, and equipment installation teams.
- Establish department goals, priorities, and operating plans that support company objectives.
- Oversee budget planning, forecasting, and expense management for technical operations.
- Lead complex technical troubleshooting, escalation management, and the resolution of issues involving hardware, software, and customer support.
- Support the evaluation, testing, and implementation of new instrumentation and technical systems.
- Collaborate with internal stakeholders to support product launches, validation processes, and training programs.
- Develop and deliver comprehensive technical training for staff, distributors, and external service partners.
- Manage relationships with external service providers, ensuring adherence to service and compliance standards.
- Oversee the development and maintenance of SOPs, technical procedures, and service documentation.
- Monitor technical support data, quality control, and calibration trends to identify and resolve performance issues.
- Work closely with quality assurance teams to align on key performance indicators and maintain audit readiness.
- Lead continuous improvement projects to enhance operational efficiency and regulatory compliance.
- Competitive base salary commensurate with experience and qualifications.
- Comprehensive benefits package including health, dental, and vision insurance.
- Retirement plan options and professional development support.
- Opportunities for career advancement within a respected and innovative organization.
- Bachelor's degree in engineering, biomedical engineering, or a related technical discipline, or equivalent education and experience.
- Extensive experience (10+ years) supporting laboratory equipment, instrumentation, or technical systems.
- Proven leadership experience in the diagnostics, laboratory, or medical device sector.
- Strong background in technical troubleshooting, service operations, and regulated work environments.
- Experience leading teams and implementing improvement initiatives in a dynamic organization.
- Advanced degree (MS, MBA, or PhD) in engineering, biomedical engineering, business, or a related field is highly regarded.
- Experience with capital equipment and complex diagnostic platforms in customer-facing roles.
- Familiarity with complaint handling, CAPA processes, validation activities, and quality systems in a technical service context.
- Demonstrated experience collaborating with distributors, third-party service providers, or operating within global service networks.
- Proven track record of leading change, process optimization, and service transformation projects.
- This Director of Biomedical Engineering role offers the chance to make a significant impact in a dynamic and growth-oriented organization.
- Working in this capacity provides valuable exposure to cutting-edge technologies and regulatory best practices, supporting both personal and professional growth.
- The organization is committed to fostering a diverse and inclusive workplace, in compliance with all applicable regulations and equal opportunity employment standards.
- Applicants are encouraged to apply by clicking the job application button to join a forward-thinking team dedicated to technical excellence and customer satisfaction.
If you are an accomplished leader with a passion for technical service and biomedical engineering, and you meet the outlined qualifications, we encourage you to take the next step in your career by submitting your application today.