Job Description
Company Description:
Stereotaxis is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, China, Japan, Canada, and elsewhere. For more information, please visit www.stereotaxis.com.
Position Summary:
The Operations Specialist will support the day-to-day manufacturing and operational activities of our medical device production team. This role plays a critical part in ensuring efficient production workflows, accurate documentation, and compliance with industry regulations. The ideal candidate is highly organized, quality-focused, and eager to contribute to a fast-paced, regulated manufacturing environment.
Essential Responsibilities:
•Assist in process improvement initiatives to enhance efficiency, reduce waste, and maintain compliance.
•Maintain and update ERP system data, ensuring accuracy and timeliness of information.
•Support daily manufacturing operations by coordinating production schedules, tracking work orders, and ensuring timely material availability.
•Assist in preparing, reviewing, and organizing manufacturing & quality documentation, including batch records, travelers, and device history records (DHRs).
•Track, compile, and report on operational metrics and KPIs to support data-driven decision-making.
•Assist in preparing financial analyses, cost breakdowns, and budget tracking reports.
•Collaborate with cross-functional teams including Production, Quality, Engineering, Supply Chain, and Finance teams to ensure smooth operations.
•Assist in preparing presentations, dashboards, and reports for leadership review.
Job Requirements
Qualifications & Skills:
•Associate’s or Bachelor’s degree in Business, Operations, Engineering, or related field (or equivalent experience).
•Previous experience in manufacturing, preferably in the medical device or other regulated industry.
•Proficiency with Microsoft Excel; experience with ERP/MRP systems preferred.
•Strong organizational skills and attention to detail.
•Ability to work collaboratively across departments and communicate effectively.
•Knowledge of GMP, ISO 13485, and FDA quality system requirements a plus.
Work Conditions:
This role is an in-office position at Stereotaxis’ Rogers, MN. site.
Culture:
Stereotaxis values steadfast integrity, intellectual excellence, responsiveness and reliability, and a dedication to constant improvement. We take pride in the positive impact of our work and in building a collaborative and innovative work environment that embraces challenge.
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