Job Title: Medical Instrumentation Engineer

Job Summary:

The Manager-Level Medical Instrumentation Engineer is responsible for overseeing the maintenance, calibration, and optimization of medical devices and systems across healthcare facilities. This role involves managing multidisciplinary teams, driving large-scale projects, ensuring strict adherence to regulatory standards, and aligning medical instrumentation operations with organizational objectives. The Manager leads innovation, optimizes processes, and ensures the reliability and compliance of all medical devices.

Key Responsibilities:

Strategic Leadership and Planning:

• Develop and implement strategies for medical device maintenance, calibration, and optimization to ensure reliable and efficient healthcare operations.
• Set objectives and allocate resources to achieve operational and compliance goals.
• Monitor key performance indicators (KPIs) to assess the efficiency and reliability of instrumentation processes.

System Oversight and Optimization:

• Oversee the maintenance, calibration, and integration of advanced medical devices, including imaging systems, ventilators, patient monitors, and laboratory equipment.
• Lead the development of preventive maintenance programs to minimize device downtime and extend equipment lifespan.
• Ensure all medical devices function optimally and meet clinical and operational requirements.

Regulatory Compliance and Quality Assurance:

• Ensure strict compliance with FDA, ISO 13485, and other applicable standards across all instrumentation operations.
• Lead internal and external audits to maintain quality certifications and address compliance gaps.
• Refine and enforce standard operating procedures (SOPs) for medical device operations and maintenance.

Team Leadership and Development:

• Manage and mentor a team of engineers and technicians, fostering a high-performing and collaborative work environment.
• Conduct performance evaluations, provide feedback, and implement training programs for professional development.
• Promote a culture of innovation, accountability, and continuous improvement within the team.

Project Management:

• Plan, execute, and oversee large-scale projects involving device installations, upgrades, and process improvements.
• Develop budgets, timelines, and resource plans to ensure successful project delivery.
• Collaborate with cross-functional teams and stakeholders to align project objectives with organizational goals.

Stakeholder Engagement and Communication:

• Serve as the primary point of contact for vendors, regulatory authorities, and internal stakeholders regarding medical instrumentation.
• Communicate technical updates, project progress, and compliance metrics effectively to senior leadership.
• Address clinical staff concerns by aligning medical device functionality with patient care needs.

Innovation and Continuous Improvement:

• Stay updated on emerging technologies and trends in medical instrumentation and healthcare operations.
• Drive innovation by introducing advanced diagnostic tools, automation, and analytics to improve device reliability and efficiency.
• Identify and implement process improvements to enhance operational outcomes and reduce costs.

Key Focus Areas:

• Strategic Oversight: Align medical instrumentation operations with organizational goals.
• Compliance Leadership: Ensure adherence to regulatory standards and quality management systems.
• Team Development: Build and mentor a high-performing team of engineers and technicians.
• Project Execution: Oversee large-scale instrumentation projects from initiation to completion.

Skills and Knowledge Required:

• Extensive knowledge of medical devices and control systems, including imaging systems, ventilators, patient monitors, and laboratory equipment.
• Expertise in regulatory standards such as FDA, ISO 13485, and healthcare quality systems.
• Advanced project management skills, including resource planning, budgeting, and timeline management.
• Strong leadership and organizational skills for managing teams and collaborating with stakeholders.
• Proficiency in data analysis tools and software for monitoring device performance and compliance.

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, regulatory compliance, or project management (e.g., ISO 13485, PMP, Lean Six Sigma) are highly desirable.

Experience:

• 10+ years of experience in medical instrumentation, with significant leadership experience managing teams and projects.
• Proven track record of implementing operational improvements and achieving compliance in healthcare environments.

Tools and Technologies:

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

Other Requirements:

• Strong decision-making abilities to address high-pressure situations effectively.
• Ability to manage multiple priorities and align technical operations with organizational objectives.
• Willingness to travel occasionally to oversee multi-site operations and projects.
• Commitment to maintaining the highest standards of safety, quality, and compliance.