Manufacturing Operator na 4 C Medical Technologies

Description

SUMMARY

The Manufacturing Operator assembles and tests advanced transcatheter mitral valve replacement (TMVR) delivery systems in a controlled cleanroom environment. This role follows detailed manufacturing procedures, ensures documentation accuracy, and contributes to continuous improvement of assembly processes to meet company and regulatory standards.

ESSENTIAL FUNCTIONS

• Assemble TMVR delivery systems according to approved procedures and work instructions.
• Collaborate with operations leadership to manage build schedules and priorities that support production goals.
• Rotate between multiple assembly and support roles as needed, maintaining strong communication across functional teams.
• Perform laser welding and Nitinol processing following completion of required training.
• Maintain accurate records, including Device History Records (DHRs) and training documentation.
• Inspect and measure components using microscopes and precision tools (e.g., calipers, laser micrometers, drop gauges).
• Identify and report process or material issues and contribute to process and product improvements.
• Follow all company and department policies, including cleanroom, safety, attendance, and quality requirements.
• Work overtime as needed to support production schedules.
• Perform other related duties as assigned.

Requirements

SKILLS AND EXPERIENCE

• Minimum of 3 years of experience in medical device manufacturing or process development.
• Ability to follow complex, multi-step manufacturing procedures with accuracy and consistency.
• Experience with Nitinol processing, laser welding, and delivery system assembly preferred.
• Working knowledge of precision inspection tools and equipment.
• Strong attention to detail, organization, and documentation accuracy.
• Effective written and verbal communication skills and ability to work collaboratively in a team environment.

PHYSICAL AND ENVIRONMENTAL

• Work is performed primarily in a cleanroom manufacturing environment. Must be able to wear cleanroom garments and adhere to gowning and sanitation procedures.
• Must be able to sit or stand for extended periods and perform repetitive hand and arm motions using fine motor skills.
• Must be able to handle and assemble small components under a microscope or magnification tools.