Catheter Assembly Technician II

Q'Apel Medical, Inc; Fremont (CA); On-site; USD 34,000 - 39,000; Full time

Job summary

Q’Apel Medical, Inc. seeks a Manufacturing Technician II / Catheter Assembler in Fremont, CA. This full‑time, non‑exempt role supports daily catheter assembly per SOP, with strict adherence to SOPs and quality standards.

The candidate will have 2–3 years of catheter assembly experience, strong manual dexterity, and the ability to work in a CER environment, following FDA QSR and ISO 13485 guidelines. Shift is 6:00 AM to 2:30 PM, Monday–Friday.

Qualifications

• Minimum 2-3 years of recent catheter assembly experience.
• Good manual dexterity and visual acuity.
• Effective communications skills (written and verbal).
• Ability to work independently or in a team setting.
• Minimum 2-3 years in a regulated medical device environment (FDA QSR & ISO 13485).
• Experience in CER is required.

Responsibilities

• Daily accurate manual assembly of the neurovascular catheter per SOP guidelines.
• Support production needs as scheduled and remain flexible.
• Perform manufacturing inspection and testing to ensure specifications are met.
• Maintain accurate documentation and records.
• Work daily in the controlled environment room (CER).
• Follow FDA QSR and ISO 13485 requirements.
• Assist Manufacturing with production issues and improvements.
• Assist in investigations and testing for new or revised procedures.
• Adhere to approved SOPs and manufacturing procedures.
• Operate microscope and cutters as required.
• Handle shipping/packaging operations and lifting of ~10 lbs.
• Provide consistent daily product output.
• Stay flexible and transition between stations and tasks.
• Communicate assembly-related issues clearly.
• Other duties as requested.

Skills

Catheter assembly

Manual dexterity

Attention to detail

Written & verbal communication

Education

High School degree

Tools

Microscope

CER environment

Manual cutters

Job description

Q’Apel Medical, Inc. seeks a Manufacturing Technician II / Catheter Assembler in Fremont, CA. This full‑time, non‑exempt role supports daily catheter assembly per SOP, with strict adherence to SOPs and quality standards.

The candidate will have 2–3 years of catheter assembly experience, strong manual dexterity, and the ability to work in a CER environment, following FDA QSR and ISO 13485 guidelines. Shift is 6:00 AM to 2:30 PM, Monday–Friday.