Catheter Operator / Assembler (Manufacturing / Production)

This position is responsible for the detailed assembly and production of high quality medical devices within manufacturing. This position includes detailed assembly and operation of various equipment and machinery. 2nd Shift Schedule, Monday - Friday 1:30pm - 9:30pm in our Bedford, MA Location.

Essential Functions:

• Ability to read, comprehend, and follow written procedures; understand and follow verbal instructions.
• Performs assembly of disposable medical devices per documented manufacturing procedures. Ability to handle and maneuver small components and parts.
• Assist engineers with process improvement, process development activities such as prototype or test sample assembly, data collection and entry, and constructive process feedback.
• Understanding of and ability to utilize electronic data collection systems and computer software packages.
• Ability to prioritize work by determining the sequencing and timing of different jobs based on precedence and importance.
• Ability to make critical decisions and judgments with minimal supervision.
• Ensure that relevant job documentation for operations and functions is accurate and up to date.
• Troubleshooting skills.
• Interpersonal skills such as conflict resolution, active participation, active listening,

interpreting, cooperation and flexibility to allow for a successful self managed team.

• Must be able to clearly communicate ideas, problems and solutions to all levels of manufacturing management in both written and oral form.
• Positively represent the company during tours by demonstrating techniques and sharing appropriate information.
• Follow safety guidelines and utilize appropriate safety devices when performing all operations.
• Participate in continuous improvement/quality initiatives in order to enhance production processes to achieve quality and profitability metrics.
• Perform routine/preventative maintenance on applicable equipment to maximize efficiency, minimize accidents to enhance longer life of equipment and tools.
• Maintain accurate records to ensure Device History Devices (DHR) and quality documents are accurate, all parts are traceable and quality issues can be addressed to assure the quality of all products.
• Demonstrates a solid understanding of Lean Manufacturing and Continuous Improvement.
• Is cross-trained in more than one manufacturing process or area of production.
• Ability to train other operators of equal or lower level as required.

Other Duties:

• Participate with the Manufacturing Supervisor/Manager in setting and monitoring individual goals and cell performance metrics that continuously seek to improve the quality of operations.
• Support all initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Qualifications:

Education:

High school degree or equivalent required

Experience:

Prefer 2 – 5 years experience working in a medical or other regulated production company