Manufacturing Technician - Balloon Components

Job Overview

The Manufacturing Technician plays a critical role in the production, development, and ongoing enhancement of balloon components used in medical device products. This position works collaboratively with Engineering, Quality, and Operations teams to support production processes, troubleshoot issues, and assist with new product introduction, all while ensuring adherence to quality standards and regulatory compliance.

Key Responsibilities

• Setup, operate, and maintain equipment used for balloon manufacturing.
• Provide assistance in process development, validation, and engineering tasks.
• Collect, analyze, and monitor manufacturing data to drive improvements.
• Identify and resolve process and equipment malfunctions, supporting corrective actions.
• Conduct both in-process and destructive testing to ensure products meet specifications.
• Accurately complete manufacturing and engineering documentation within designated timelines.
• Train operators on approved manufacturing protocols and instructions.
• Contribute to continuous improvement efforts aimed at improving quality, yield, productivity, and operational efficiency.
• Participate in change control management, non-conformance resolution, and CAPA initiatives.
• Comply with GMP, ISO standards, safety, and quality system regulations.
• Maintain cleanliness and organization of the work area using 5S methodology.
• Engage actively in team meetings and cross-functional projects.

Educational & Experience Requirements

• Experience in medical device balloon manufacturing or other regulated manufacturing settings.
• Strong attention to detail and dedication to quality assurance.
• Familiarity with following documented procedures and maintaining manufacturing records accurately.
• Preferred: Technical Diploma or equivalent qualification.
• Preferred: Hands-on experience in balloon development and supporting engineering, process development, or NPI activities.

Skills and Competencies

• Technical and mechanical aptitude with the ability to interpret technical drawings, specifications, and work instructions.
• Proficiency in troubleshooting and problem-solving techniques.
• Effective communication and organizational capabilities.
• Ability to work autonomously as well as collaboratively within teams.
• Competent in documenting and analyzing manufacturing performance data.
• Capable of working in controlled, cleanroom manufacturing environments.
• Mindset oriented towards continuous improvement emphasizing quality and operational efficiency.

Working Conditions and Physical Requirements

The role requires regular interaction with computers, reports, and documentation. Physical demands include frequent use of hands for keyboard or calculator operation, regular periods of sitting, speaking, listening, standing, and walking. Reasonable accommodations will be considered to support individuals with disabilities in performing essential duties effectively.

Additional Information

Minimal travel is required. The company is committed to equal employment opportunity without discrimination based on legally protected categories. Employment is contingent upon successful completion of pre-employment drug screening and background checks in accordance with applicable laws.