Process Development Engineer

Shift Type

Job Title

Process Development Engineer

Education

Bachelor's Degree

Location

Minneapolis, MN 55401 US (Primary)

Stereotaxis - St. Louis, MO 63101 US

Career Level

Experienced (Non-Manager)

Category

Manufacturing

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 process development engineer will provide technical support and operating knowledge for our medical device operation. This role will conduct critical engineering functions such as validation, troubleshooting, and identifying and implementing process improvements. The engineer will work with cross-functional teams to support transfer of products into production. The role will also be required to work with external vendors to design and specify tooling / fixturing. This position will focus on developing various processes and implementing those into production through thorough validations by working closely with R&D, Quality, Manufacturing and Operations teams.

Essential Responsibilities :

• Design and develop manufacturing processes, tooling, and fixtures to meet new product program schedules, enhancing product quality and taking into consideration problems inherent in the transfer of technology from research to manufacturing.
• Drive process improvements and validations through manufacturing implementation.
• Make recommendations concerning the acquisition and use of new technological equipment and materials.
• Author and execute validation protocols and reports including installation qualifications (IQ), operational qualifications (OQ), performance qualifications (PQ), and process performance qualifications (PPQ).
• Utilize methodologies and statistical analyses, such as DMAIC, Gage R&R, Cp / Cpk and SPC, to analyze and improve processes, components and products.
• Work with cross-functional teams including R&D, Quality, Operations, and Regulatory teams. Collaborate with R&D to ensure adherence to Design for Manufacturability (DFM) principles.
• Read & create engineering drawings, including dimensions, tolerances, and schematics.
• Understand principles of Cost of Goods Sold (COGS) including material, direct labor, and overhead costs as well as in consideration to manufacturing process yields.
• Comply with U.S. Food and Drug Administration (FDA) regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Job Requirements

Qualifications & Skills :

Work Conditions :

This role is an in-office position at Stereotaxis' Rogers MN location.

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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