Manager, System & Device Testing

Stereotaxis; St. Louis (MO); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Manager for System & Device Testing to oversee daily responsibilities in user documentation and product testing. This role is vital for ensuring the quality of innovative robotic technologies that enhance patient care. You will lead a team of engineers, develop project schedules, and establish testing standards, all while working in a collaborative environment that values integrity and excellence. If you have extensive experience in medical device testing and a passion for innovation, this position could be your next career milestone.

Qualifications

• 5-10+ years' experience as a test engineer for sterile devices.
• Familiarity with FDA medical device regulatory guidelines.

Responsibilities

• Manage system and device test engineers for product quality.
• Create and maintain verification and validation plans.
• Test new products and software upgrades for release.

Skills

Test Method Validation

Fixture Design & Development

Statistical Sampling

Medical Device Testing

Team Management

Effective Communication

Education

Bachelor's Degree in Engineering

Job description

Shift Type

Job Title

Manager, System & Device Testing

Education

Bachelor's Degree

Location

Stereotaxis - St. Louis, MO 63101 US (Primary)

Career Level

Manager

Category

R&D

Date Needed By

Job Type

Full-time

Travel

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.

Hiring Manager

Exemption Type

# of Hires Needed

1

Wage Amount