Manager, System & Device Testing

Stereotaxis, Inc.St. Louis, MO, US

job_description.job_card.30_days_ago

serp_jobs.job_preview.job_type

serp_jobs.job_card.full_time

job_description.job_card.job_description

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 Manager, System & Device Testing will manage the daily responsibilities for user documentation, device, software, and hardware testing. In conjunction with the development team, they will ensure overall quality of the products released to customers and proper documentation of the products.

Essential Responsibilities :

Responsible for functional management of assigned team of system and device test engineers
Responsible for creation and maintenance of verification and validation plans, protocols, and reports
Responsible for helping develop, and managing to, detailed project schedules
Responsible for testing new products and software upgrades for release
Establish standards for the testing and documentation of all products
Maintaining the development and test environments

Job Requirements

Qualifications & Skills :

BS in an Engineering discipline highly preferred

5-10+ years’ experience as test engineer for sterile devices, software and hardware highly preferred

Experience in test method validation, fixture design & development, and statistical sampling & rationale highly preferred

Experience in the development and testing of medical devices highly preferred

Experience with required documentation for medical devices highly preferred

Familiarity with FDA medical device regulatory guidelines and pathways highly preferred

Management experience preferred

Ability to communicate effectively, multi-task and manage several projects at once

Legally authorized to work in the United States

Work Conditions :

This role is an in-office position at Stereotaxis’ headquarters.

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.

serp_jobs.job_alerts.create_a_job

Testing Manager • St. Louis, MO, US