Job Title: Biomedical Engineer (Instrumentation)

Job Summary:

The Senior Biomedical Engineer (Instrumentation) is responsible for overseeing the maintenance, calibration, and optimization of advanced biomedical devices and systems in healthcare environments. This role involves managing complex technical challenges, leading strategic projects, and ensuring compliance with regulatory standards such as FDA and ISO 13485. The senior engineer mentors junior team members, drives innovation, and collaborates with clinical and technical teams to enhance the reliability and performance of medical devices.

Key Responsibilities:

System Maintenance and Optimization:

• Lead the calibration, testing, and maintenance of advanced biomedical devices, including imaging systems, patient monitors, infusion pumps, and ventilators.
• Develop and oversee preventive maintenance schedules to ensure maximum device uptime and reliability.
• Evaluate device performance metrics and implement strategies to optimize system efficiency.

Troubleshooting and Advanced Diagnostics:

• Diagnose and resolve complex technical issues in biomedical instrumentation using advanced diagnostic tools and software.
• Conduct root cause analyses for recurring malfunctions and implement long-term corrective actions.
• Collaborate with vendors, manufacturers, and technical teams to resolve critical device challenges.

Device Integration and Upgrades:

• Manage the installation, integration, and commissioning of new biomedical equipment across healthcare systems.
• Validate device compatibility and performance following installations, upgrades, or retrofits.
• Lead retrofitting projects to align legacy systems with current technologies and regulatory standards.

Regulatory Compliance and Quality Assurance:

• Ensure all biomedical operations comply with FDA, ISO 13485, IEC 60601, and other applicable healthcare standards.
• Lead internal and external audits to maintain quality certifications and regulatory compliance.
• Refine and enforce standard operating procedures (SOPs) for device maintenance and operations.

Leadership and Mentorship:

• Mentor and guide junior and mid-level engineers, fostering skill development and professional growth.
• Conduct technical training sessions to build team proficiency in advanced biomedical instrumentation.
• Act as a subject matter expert for resolving complex technical challenges and implementing best practices.

Collaboration and Stakeholder Engagement:

• Work closely with clinical staff and healthcare teams to ensure devices meet operational and patient care needs.
• Act as a key liaison between internal teams, vendors, and regulatory authorities regarding biomedical instrumentation.
• Provide regular updates to senior management on system performance, compliance metrics, and project progress.

Innovation and Continuous Improvement:

• Drive innovation by researching and implementing emerging technologies in biomedical instrumentation.
• Lead initiatives to automate maintenance workflows and enhance device reliability.
• Identify opportunities for process improvements and implement solutions to enhance operational outcomes.

Key Focus Areas:

• Advanced Troubleshooting: Resolve complex technical issues and ensure long-term system reliability.
• Leadership and Mentorship: Lead teams, mentor junior staff, and share technical expertise.
• Strategic Oversight: Align biomedical operations with organizational goals and regulatory standards.
• Compliance Excellence: Ensure adherence to healthcare standards and manage quality assurance efforts.

Skills and Knowledge Required:

• Advanced knowledge of biomedical devices and systems, including imaging devices, ventilators, patient monitors, and laboratory equipment.
• Strong expertise in healthcare regulations and standards (e.g., FDA, ISO 13485, IEC 60601).
• Advanced troubleshooting and diagnostic skills with proficiency in using calibration tools and diagnostic software.
• Effective leadership and communication skills for managing teams and collaborating with stakeholders.
• Analytical skills for data-driven decision-making and identifying process improvement opportunities.

Educational Qualifications:

• Bachelor’s or Master’s degree in Biomedical Engineering, Instrumentation Engineering, Electronics Engineering, or a related technical field.
• Advanced certifications in medical device management, quality systems, or regulatory compliance (e.g., ISO 13485, Lean Six Sigma, PMP) are highly desirable.

Experience:

• 7-10 years of experience in biomedical instrumentation, including leading teams and managing large-scale projects.
• Demonstrated ability to resolve complex technical challenges and implement operational improvements.

Tools and Technologies:

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

Other Requirements:

• Strong organizational and decision-making abilities to manage multiple high-priority tasks.
• Willingness to work in dynamic healthcare environments and travel to multiple facilities if required.
• Commitment to maintaining safety, quality, and compliance across all operations.