What are the responsibilities and job description for the Director of Service and Repair Operations position at MPE-Inc?
Job Summary:
MPE, Inc. is establishing a new Service and Repair Department to provide high-quality support for our customers in hospitals, surgery centers, and clinics. The Director of Service and Repair Operations will play a foundational leadership role in building this department from the ground up. This position is responsible for designing and implementing all processes, procedures, infrastructure, and team structure to efficiently receive, diagnose, repair, and return medical equipment and devices to end users. The Director will ensure regulatory compliance, operational excellence, customer satisfaction, and long-term profitability of the service function.
Essential Duties and Responsibilities:
Department Development & Strategy
- Lead the design and implementation of the full service and repair operating model, including intake of field-returned products, diagnostics, repair quoting (time and materials), inventory management, and outbound shipping to customers
- Establish service level agreements (SLA), turnaround time targets, pricing models, and performance metrics
- Develop and optimize repair facility layout, tooling, test equipment, and supporting IT systems (service management software, parts inventory, CRM integration, etc.)
- Create scalable workflows and standard operating procedures that integrate with MPE’s manufacturing and quality systems
Regulatory Compliance & Quality Assurance
- Ensure all service and repair activities comply with FDA 21 CFR Part 820 (Quality System Regulation), ISO 13485, and other applicable medical device regulations and standards.
- Develop and maintain roust documentation, traceability, risk management, failure analysis, and post-repair validation processes.
- Lead internal audits, CAPA programs, and continuous improvement initiatives.
Team Leadership & Operations
- Recruit, hire, train and lead a high-performing team of service technicians, diagnosticians, logistics staff, and support personnel
- Design and deliver technical training programs specific to MPE products and regulatory requirements.
- Oversee daily operations, including triage, repair execution, quality control, parts management and logistics.
- Manage vendor relationships for specialist repairs or outsourced services
Business & Customer Focus
- Serve as the primary escalation point for service-related customer issues.
- Analyze repair data to identify trends and provide actionable feedback to Engineering and Manufacturing teams for product improvements
- Develop and manage the department budget, forecasts, and P&L performance
- Collaborate closely with Sales, Engineering, Quality and Manufacturing leadership
Skills & Competencies
- Strong technical aptitude and understanding of electromechanical systems
- Excellent leadership, coaching and team building skills
- Data-driven decision making with strong analytical and problem-solving skills
- Superior communication and customer service skills
- Ability to thrive in a fast-paced, growing environment
Education
- Bachelor’s degree in Engineering, Operations Management, Business Administration, or a related technical field (Master’s Degree preferred)
Experience and/or Training
Required:
- 8-12 years of pregressive experience in medical device service, repair or field operations.
- Minimum 4 years of leadership experience at the Manager or Director level, preferably building or scaling a service/repair organization.
- Strong working knowledge of FDA regulations (21 CFR Part 820) and ISO 13485
- Prove experience in a regulated environment supporting capital medical equipment (electromechanical, surgical or robotic systems)
Preferred:
- Six Sigma Certification (Green or Black Belt) or equivalent process improvement experience
- Certification in Biomedical Equipment Technology (CBET) or ASQ quality certifications
- Experience with depot-level repair operations and third-party service models
- Ability to thrive in a fast-paced, growing company environment