Job Title: Biomedical Engineer (Instrumentation)

Job Summary:

The Manager-Level Biomedical Engineer (Instrumentation) is responsible for overseeing the operation, maintenance, and strategic management of biomedical devices and instrumentation systems across healthcare facilities. This role involves developing long-term strategies, ensuring compliance with regulatory standards, managing multidisciplinary teams, and aligning biomedical operations with organizational objectives. The manager is a key driver of innovation, operational efficiency, and quality assurance.

Key Responsibilities:

Strategic Leadership and Planning:

• Develop and implement strategies for the maintenance, calibration, and optimization of biomedical devices and systems.
• Define team objectives, allocate resources, and establish performance metrics to achieve operational goals.
• Monitor and analyze key performance indicators (KPIs) to drive continuous improvement and operational excellence.

System Oversight and Optimization:

• Oversee the operation, calibration, and maintenance of advanced biomedical devices, including imaging systems, patient monitors, and laboratory equipment.
• Ensure the implementation of preventive maintenance schedules to minimize downtime and extend device lifespan.
• Evaluate and adopt emerging technologies to enhance device performance and operational efficiency.

Regulatory Compliance and Quality Assurance:

• Ensure all biomedical operations comply with regulatory standards such as FDA, ISO 13485, and IEC 60601.
• Lead internal and external audits to maintain certifications and address compliance requirements.
• Refine and enforce standard operating procedures (SOPs) to uphold quality and safety standards.

Team Leadership and Development:

• Manage and mentor a team of engineers and technicians, fostering a culture of accountability, collaboration, and continuous learning.
• Conduct performance evaluations, provide feedback, and implement training programs to enhance team skills.
• Build and maintain a high-performing team capable of addressing complex technical and operational challenges.

Project Management:

• Lead large-scale projects, including the installation, integration, and commissioning of biomedical systems.
• Develop and manage project budgets, timelines, and resources to ensure successful execution.
• Collaborate with cross-functional teams and vendors to align project objectives with organizational goals.

Stakeholder Engagement and Communication:

• Serve as the primary liaison between internal teams, clinical staff, and external stakeholders regarding biomedical operations.
• Provide regular updates to senior leadership on system performance, compliance metrics, and project progress.
• Address operational and technical concerns raised by healthcare teams to improve device functionality and reliability.

Innovation and Continuous Improvement:

• Drive innovation by identifying and implementing advancements in biomedical technology and practices.
• Lead initiatives to automate maintenance workflows and integrate predictive maintenance tools.
• Identify opportunities for process improvements and implement strategies to enhance operational efficiency and reduce costs.

Key Focus Areas:

• Strategic Leadership: Align biomedical operations with organizational objectives and industry advancements.
• Compliance Leadership: Ensure adherence to healthcare standards and maintain quality certifications.
• Team Management: Build, mentor, and lead a multidisciplinary team of engineers and technicians.
• Project Execution: Oversee large-scale projects, ensuring alignment with timelines and budgets.

Skills and Knowledge Required:

• Comprehensive knowledge of advanced biomedical devices and systems, including imaging devices, ventilators, and diagnostic tools.
• Expertise in regulatory standards and quality systems such as FDA, ISO 13485, and IEC 60601.
• Advanced project management skills, including resource planning, budgeting, and risk management.
• Strong leadership, organizational, and communication skills for managing teams and stakeholders.
• Analytical and decision-making skills to address complex operational challenges effectively.

Educational Qualifications:

• Bachelor’s or Master’s degree in Biomedical Engineering, Instrumentation Engineering, Electronics Engineering, or a related technical field.
• Advanced certifications in project management (e.g., PMP, PRINCE2), quality systems (e.g., ISO 13485), or healthcare compliance are highly desirable.

Experience:

• 10+ years of experience in biomedical instrumentation, with at least 3-5 years in a leadership role managing teams and projects.
• Proven ability to align technical operations with organizational goals and deliver successful outcomes.

Tools and Technologies:

• Proficiency in diagnostic tools, calibration equipment, and software used for biomedical devices.
• Familiarity with automation and predictive maintenance technologies.
• Advanced knowledge of project management tools (e.g., MS Project, Primavera).

Other Requirements:

• Strong organizational and multitasking skills to manage diverse priorities effectively.
• Willingness to travel to multiple facilities to oversee operations and projects.
• Commitment to maintaining high standards of safety, quality, and compliance across all activities.