Manufacturing Technician II

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

Position Title: Manufacturing Technician II / Catheter Assembly Technician

Job Location: 4245 Technology Drive, Fremont, CA 94538

Worker Category: Full-Time/Non-Exempt

Job Industry: Neurovascular Medical Devices (Catheters)

Schedule: Monday - Friday

Shift: 6:00 AM - 2:30 PM

Who We Want:

Q’Apel is seeking a Manufacturing Technician II / Catheter Assembler to support and maintain efficient, timely, and effective production operations. A minimum of 2-3 years of manual catheter assembly experience in the Neurovascular Devices Industry, Neurointerventional, Endovascular Neurosurgery, Neuro-interventional, Coronary or Peripheral Medical Device sectors is required to be considered. The ideal candidate will have recent hands‑on experience assembling neurovascular catheters, demonstrating excellent manual dexterity, visual acuity, strong attention to detail, and the ability to follow strict instructions. The assembly process must be followed exactly from the written Standard Operating Procedures (SOP’s) to meet safety and high-quality standards. We’re looking for someone who has proven and proficient microscope skills capable of performing detailed assembly and inspection tasks for extended periods (up to 8 hours per day). Can safely and effectively operate manual cutting tools and other assembly equipment. Follows work instructions accurately and consistently to ensure high product quality and deliver on output. The ideal assembly technician must be comfortable working in a dynamic environment with rapidly changing priorities and demonstrate flexibility to quickly adjust to new tasks and assignments as needed. At Q’Apel, every team member “steps up to the plate.” We are a fast‑paced, high‑growth company with a startup mindset. We value collaboration, adaptability, and a positive attitude toward change. If you thrive in a dynamic environment and take pride in precision work, we’d love to have you on our team.

What You’ll Work On:

• Daily accurate manual assembly of the neurovascular catheter per SOP guidelines.
• Supports production needs as scheduled and remains flexible.
• Performsmanufacturinginspectionandtestingof catheter productstoensuretheymeetspecifications.
• Accurate documentation and consistent records maintenance.
• Working daily in the controlled environment room (CER).
• Accurately and consistently follow FDA Quality Systems Regulations and ISO 13485
• Assists Manufacturing with production issues and improvements.
• Assistsininvestigationsandtestingforneworrevisedproductionprocedures.
• Adherestoapprovedstandardoperatingproceduresandmanufacturingprocedures.
• Unlimited/continuoususeofamicroscope.
• Unlimited/continuoususeofmanualcutters.
• Opening,lifting,andpackagingshipperboxesapproximately10lbs.inweightonacontinuous basis.
• Provide consistent daily product output.
• Ability to stay flexible and transition from one station to another, one task to another.
• Daily communication and ability to clearly explain any assembly-related problems.
• Other duties as requested.

WhatYouBring:

Education:High School degree required

Experience&Skills required:

• Minimum 2-3 years of recent catheter assembly experience required.
• Goodmanualdexterityandvisualacuity required.
• Effectivecommunicationskills(bothwrittenandverbal)required.
• Abilitytoworkindependentlyorinateamsetting.
• Abilitytoliftupto10lbs
• Isorganizedandself-motivated
• Minimum 2-3 years of experience working in a regulated industry (medical device development experience, along with a solid working knowledge of FDA Quality System Regulations and ISO 13485)
• Minimum 2-3 years of experience working in a controlled environment room (CER) required
• Knowledge and exposure to applicable regulations (QSR, MDD, CMDR, and ISO) required

Our hourly compensation ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. After you join the company your performance, contributions, and results along with business and organizational needs will affect your hourly compensation. The hourly compensation range for this full-time, non-exempt position is between $25.00/hour to $28.00/hour.

This document contains confidential, proprietary information of Q’Apel Medical, Inc. It may not be copied or reproduced without prior written permission from Q’Apel Medical, Inc