Repair Center Manager

Nihon Kohden America•Irvine, CA

19d•$94,000 - $132,000

About The Position

The Repair Center Manager oversees and directs all operations within the Repair Center, ensuring that repairs, maintenance, and refurbishments of medical devices are completed efficiently, accurately, and in compliance with company standards and regulatory requirements. This role involves leading a team of skilled technicians, managing workflows, maintaining quality control, and collaborating closely with other departments to ensure high levels of customer satisfaction. Essential Functions and Main Duties Oversee day-to-day operations of the repair center, ensuring efficient workflow and high-quality repairs Develop and implement standard operating procedures (SOPs) for repair and refurbishment processes Define and monitor key performance indicators (KPIs) to ensure operational efficiency and identify areas for improvement Manage inventory of repair parts and tools, ensuring optimal stock levels for timely repairs Implement and maintain quality control processes to ensure repaired devices meet or exceed industry standards Conduct regular audits and inspections to ensure compliance with internal and external standards Develop and maintain documentation for repair procedures and quality management systems Ensure timely communication with customers regarding repair status, timelines, and any potential issues Manage the Repair Center budget, ensuring that costs are controlled and financial targets are met Identify opportunities for cost savings and process improvements without compromising quality Prepare regular reports on Repair Center performance, including turnaround times, repair rates, and customer satisfaction metrics Select, manage, develop, and hold accountable team members to meet department deliverables and responsibilities. Complete company people management requirements; exhibit manager competencies Adheres to all company policies, procedures, and business ethics codes Duties may be modified or assigned at any time based on business need

Requirements

Bachelors degree in biomedical engineering, electrical engineering, or related field; relevant education and experience accepted in lieu of degree
3+ years experience working in a repair, manufacturing or related environment
5+ years of leadership experience and/or people management experience, including driving results through others, leading teams or projects, and providing training
Knowledge of FDA regulations (including Medical Device Reporting), ISO 13485, and other standards related to medical device repair
Experience with quality management systems and Lean manufacturing principles
Excellent leadership and team management skills
Strong problem-solving and analytical skills
Exceptional communication skills, both verbal and written
High level of attention to detail, ensuring accuracy in repairs and compliance with standards
Proficiency in Microsoft Office suite and repair management software
The ability to work effectively under pressure in a fast-paced, time-sensitive environment with shifting priorities and multiple deadlines
Ability to define project scope, statement of work, work breakdown schedule, sub-tasks, and required resources on new Repair Center projects
Must be able to communicate verbally and in writing, and to receive and understand verbal and written instructions in English
Able to work effectively both independently and in a collaborative team environment

Nice To Haves

Advanced degree or certification in medical device technology is preferred

Responsibilities

Oversee day-to-day operations of the repair center, ensuring efficient workflow and high-quality repairs
Develop and implement standard operating procedures (SOPs) for repair and refurbishment processes
Define and monitor key performance indicators (KPIs) to ensure operational efficiency and identify areas for improvement
Manage inventory of repair parts and tools, ensuring optimal stock levels for timely repairs
Implement and maintain quality control processes to ensure repaired devices meet or exceed industry standards
Conduct regular audits and inspections to ensure compliance with internal and external standards
Develop and maintain documentation for repair procedures and quality management systems
Ensure timely communication with customers regarding repair status, timelines, and any potential issues
Manage the Repair Center budget, ensuring that costs are controlled and financial targets are met
Identify opportunities for cost savings and process improvements without compromising quality
Prepare regular reports on Repair Center performance, including turnaround times, repair rates, and customer satisfaction metrics
Select, manage, develop, and hold accountable team members to meet department deliverables and responsibilities.
Complete company people management requirements; exhibit manager competencies
Adheres to all company policies, procedures, and business ethics codes
Duties may be modified or assigned at any time based on business need