Catheter Assembly Technician II — Neurovascular Precision

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

Job summary

Q’apel Medical in Fremont, CA is seeking a Manufacturing Technician II / Catheter Assembler. The role requires 2–3 years of catheter assembly experience and strong manual dexterity for precise neurovascular catheter work.

You will follow SOPs, document everything accurately, and work in a controlled environment room (CER) daily. Candidates must be able to lift up to 10 lbs, operate microscopes and cutting tools, and adapt to changing priorities while maintaining quality and compliance with FDA

Qualifications

• Minimum 2–3 years of catheter assembly experience.
• Good manual dexterity and visual acuity.
• Effective written and verbal communication skills.
• Ability to work independently or in a team setting.
• Ability to lift up to 10 lbs.
• Organized and self-motivated.
• Experience in a regulated medical device environment with FDA QSR and ISO 13485.
• Experience working in a CER.
• Familiarity with applicable regulations (QSR, MDD, CMDR, ISO).

Responsibilities

• Assemble neurovascular catheters daily per SOP guidelines.
• Support production needs as scheduled and remain flexible.
• Inspect and test catheter products to ensure specifications.
• Maintain accurate documentation and records.
• Work daily in the CER.
• Follow FDA QSR and ISO 13485 requirements.
• Assist with production issues and process improvements.
• Assist in investigations and testing for new procedures.
• Follow approved SOPs and manufacturing procedures.
• Operate microscopes and manual cutters as required.
• Handle packaging and shipping tasks.

Skills

Catheter assembly

Manual dexterity

Visual acuity

Written and verbal communication

Teamwork / independence

Lifting 10 lbs

Attention to SOPs

Regulatory knowledge (FDA QSR/ISO 1345

Education

High School diploma

Tools

Microscope

CER environment tools

Job description

Q’apel Medical in Fremont, CA is seeking a Manufacturing Technician II / Catheter Assembler. The role requires 2–3 years of catheter assembly experience and strong manual dexterity for precise neurovascular catheter work.

You will follow SOPs, document everything accurately, and work in a controlled environment room (CER) daily. Candidates must be able to lift up to 10 lbs, operate microscopes and cutting tools, and adapt to changing priorities while maintaining quality and compliance with FDA