Capital Equipment, Cardiovascular Disease, Change Control, Continuous Improvement, Corrective Action, Cross-Functional, Detail Oriented, Documentation, Electromechanics, Identify Issues, Machine Tool, Manufacturing, Manufacturing Engineering, Medical Equipment, Patient Care, Problem Solving Skills, Process Improvement, Process Validation, Product Support, Product/Service Launch, Quality System Requirements (QSR), Regulations, Root Cause Analysis, Team Player
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 Manufacturing Engineer will support the manufacturing of complex medical device capital equipment. This role focuses on supporting new product introductions, improving production processes, and ensuring product quality and compliance within a regulated environment. The ideal candidate is hands-on, detail-oriented, and eager to grow in a collaborative, fast-paced setting.
Essential Responsibilities:
- Support design transfer and manufacturing of electromechanical capital equipment medical devices
- Assist in developing and maintaining manufacturing work instructions and procedures
- Troubleshoot production issues and implement corrective actions
- Collaboration with design team on new product introductions
- Assist with fixture and tooling design to improve manufacturability
- Conduct root cause investigations using structured problem-solving methods
- Help maintain manufacturing documentation in compliance with quality system requirements
- Support supplier and incoming inspection activities as needed
- Support ongoing manufacturing and continuous improvement activities (e.g., change control implementation, material disposition determination, identification and replacement of obsolete items, etc.)
- Work cross-functionally with Quality, Regulatory, and Operations teams
- Participate in process validation activities (IQ/OQ/PQ) and equipment qualification