Manufacturing Technician II

About this position

About Q'apel Medical, Inc

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.

Manufacturing Technician II / Catheter Assembly Technician

4245 Technology Drive, Fremont, CA 94538

Operations Mfg Techs

Full‑Time/Hourly

Non‑Exempt

Assembly Technician

Assembly Technician 2

Monday – Friday

6:00 AM – 2:30 PM

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 or related sectors is required. The ideal candidate will have recent hands‑on experience assembling neurovascular catheters, 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 (SOPs) to meet safety and high‑quality standards. We need someone with proven microscope skills capable of performing detailed assembly and inspection tasks for extended periods (up to 8 hours per day). 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.

• Daily accurate manual assembly of the neurovascular catheter per SOP guidelines.
• Support production needs as scheduled and remain flexible.
• Perform manufacturing inspection and testing of catheter products to ensure they meet specifications.
• Accurate documentation and consistent record maintenance.
• Work daily in the controlled environment room (CER).
• Accurately and consistently follow FDA Quality Systems Regulations and ISO 13485.
• Assist manufacturing with production issues and improvements.
• Assist in investigations and testing for new or revised production procedures.
• Adhere to approved standard operating procedures and manufacturing procedures.
• Use microscope continuously.
• Use manual cutters continuously.
• Open, lift, and package shipment boxes (approx. 10 lb each) on a continuous basis.
• Provide consistent daily product output.
• Stay flexible and transition from one station to another, one task to another.
• Communicate daily and clearly explain any assembly‑related problems.
• Other duties as requested.

Education:

High School degree required.

Experience &

Skills:

• Minimum 2–3 years of recent catheter assembly experience.
• Good manual dexterity and visual acuity.
• Effective communication skills (both written and verbal).
• Ability to work independently or in a team setting.
• Ability to lift up to 10 lb.
• Organized and self‑motivated.
• Minimum 2–3 years of experience working in a regulated industry (medical device development experience, with solid 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).

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 + equity + benefits.

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.