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Nihon Kohden America · 4 months ago

Repair Center Manager

Irvine, CA

Full-time

Onsite

Mid, Senior Level

$94K/yr - $132K/yr

3+ years exp

Nihon Kohden America is a company focused on medical devices, and they are seeking a Repair Center Manager to oversee and direct all operations within the Repair Center. The role involves leading a team of technicians, managing workflows, maintaining quality control, and ensuring compliance with company standards and regulatory requirements.

BiotechnologyHealth CareMedical

H1B Sponsor Likely

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

Qualification

Biomedical engineeringMedical device technology certificationFDA regulations knowledgeQuality management systemsLean manufacturing principlesRepair management softwareLeadership experienceProblem-solving skillsCommunication skillsAttention to detailTeam management skills

Required

Bachelor's 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

Preferred

Advanced degree or certification in medical device technology

Company

Nihon Kohden America

Nihon Kohden America’s monitoring division develops solutions to improve patient safety and better control costs.

Founded in 1979

Irvine, California, USA

201-500 employees

http://us.nihonkohden.com

H1B Sponsorship

Nihon Kohden America has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (2)

2024 (2)

2023 (1)

2022 (5)

2021 (2)