Manufacturing 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

At Q’Apel, we are passionate about revolutionizing neurovascular access. In the simplest sense, we’re a company that creates solutions. We design novel access device technology for vascular interventions and unmet clinical needs. Because in the precious seconds that surround a stroke emergency, clinicians need technology that delivers. That’s where Q’Apel comes in.

Successful Q’Apel team members step up to the plate and work together to achieve our goals every single day. We are a fast-paced, high-growth company with a startup philosophy that requires an all-hands-on-deck attitude, taking on all changes with excitement and a great attitude.

Position Title: Manufacturing Technician II / Catheter Assembly Technician

Job Location: 4245 Technology Drive, Fremont, CA 94538

Department: Operations Mfg Techs

Worker Category: Full-Time/Hourly

FLSA: Non-Exempt

Function: Assembly Technician

Job Class: Assembly Technician 2

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. In addition to those factors, we also examine internal equity as well as consider the current market rate, and the title may be assessed one level lower or higher accordingly. 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