Manufacturing Engineer

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

Qualifications & Skills:
Bachelors degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Biomedical Engineering, or related field
03 years of engineering experience (internships or co-ops acceptable)
Basic understanding of manufacturing processes and engineering principles
Strong problem-solving and analytical skills
Excellent written and verbal communication skills
Proficiency with Microsoft Office tools Preferred:
Experience in medical device or regulated industry (FDA, ISO 13485)
Exposure to electromechanical assemblies
Familiarity with CAD software (SolidWorks)
Knowledge of Lean Manufacturing concepts
Experience with ERP systems and change control processes
Understanding of Design for Manufacturability (DFM) principles

Key Competencies:
Hands-on mechanical aptitude
Attention to detail
Team collaboration
Continuous improvement mindset
Ability to manage multiple priorities
Technical curiosity and willingness to learn

Working Conditions:
Combination of office and manufacturing floor environment
May require occasional lifting (up to 25 lbs)
Hands-on work with production equipment and assemblies

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.