Manufacturing Assembler

Katalyst CRO; Salt Lake City (UT); On-site; USD 40,000 - 60,000; Full time

Job summary

Katalyst CRO is looking for an experienced Manufacturing/Assembly Technician in Salt Lake City, Utah. This role involves supporting the fabrication, assembly, and testing of medical devices in a regulated environment. Candidates should have experience with mechanical assembly, chemical mixing, and quality inspections while adhering to SOPs and GMP standards.

Key responsibilities include mechanical assembly of devices, executing sample builds, and maintaining accurate production documentation. Collaboration with engineering and quality teams is essential for success.

Qualifications

• Hands-on experience with mechanical assembly, sample builds, and chemical mixing.
• Experience following SOPs and GMP standards.
• Ability to perform visual inspections and work collaboratively.

Responsibilities

• Perform precision mechanical assembly of medical devices.
• Execute sample builds following engineering protocols.
• Inspect and document manufactured samples.

Skills

Mechanical assembly

Chemical mixing

Quality inspections

Using precision tools

Tools

Specialized manufacturing equipment

Job description

Job Summary

Seeking an experienced Manufacturing/Assembly Technician to support the fabrication, assembly, testing, and preparation of medical devices in a regulated manufacturing environment. The ideal candidate will have hands‑on experience with mechanical assembly, sample builds, chemical mixing, precision tools, quality inspections, and manufacturing documentation while following SOPs and GMP standards.

Key Responsibilities

• Perform precision mechanical assembly of medical devices and components.
• Execute sample builds following engineering protocols and manufacturing procedures.
• Mix chemical formulations according to documented work instructions.
• Operate specialized manufacturing equipment and tooling.
• Heat‑form catheter tips and assemble catheter components.
• Apply coatings and lubrication to catheters and guidewires.
• Inspect, photograph, document, and characterize manufactured samples.
• Prepare products for conditioning, testing, and engineering evaluation.
• Perform visual inspections using microscopes and precision measuring equipment.
• Follow SOPs, GMP, GDP, and quality system requirements.
• Maintain accurate production and quality documentation.
• Troubleshoot equipment issues and notify engineering when abnormalities occur.
• Support continuous improvement and process optimization initiatives.
• Rotate between manufacturing operations based on production needs.
• Maintain a clean, organized, and safe work environment.
• Work collaboratively with engineering, quality, and manufacturing teams.