Manufacturing Technician II

About QApel:

At QApel, we are passionate about revolutionizing neurovascular access. In the simplest sense, were 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. Thats where QApel comes in.

Successful QApel 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

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:

QApel 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 QApel, 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, wed love to have you on our team.

What Youll Work On:

• Daily accurate manual assembly of the neurovascular catheter per SOP guidelines.
• Supports production needs as scheduled and remains flexible.
• Performs manufacturing inspection and testing of catheter products to ensure they meet specifications.
• 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.
• Assists in investigations and testing for new or revised production procedures.
• Adheres to approved standard operating procedures and manufacturing procedures.
• Unlimited/continuous use of a microscope.
• Unlimited/continuous use of manual cutters.
• Opening, lifting, and packaging shipper boxes approximately 10 lbs. in weight on a continuous 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.

What You Bring:

Education: High School degree required

Experience & Skills required:

• Minimum 2-3 years of recent catheter assembly experience required.
• Good manual dexterity and visual acuity required.
• Effective communication skills (both written and verbal) required.
• Ability to work independently or in a team setting.
• Ability to lift up to 10 lbs
• Is organized and self-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 QApel Medical, Inc. It may not be copied or reproduced without prior written permission from QApel Medical, Inc

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