Catheter Assembler Medical Device / Manufacturing Technician II

Position Title: Manufacturing Technician II/Assembler                            Job Location: 4245 Technology Drive, Fremont, CA 94538

Department: Operations                                                                          Worker Category: Full-Time/Hourly

Schedule: Monday - Friday                                                                      Shift: 8:00 AM - 4:30 PM

About Q’Apel:

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.

Who We Want:

Q’Apel is looking for an experienced Manufacturing Technician II to assemble Neurovascular Medical Devices, specifically Catheter Assembler. Manufacturing Technician II will be responsible for manually assembling neurovascular catheters and maintaining efficient, timely and cost-effective production line needs.

What You’ll 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
• 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 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 equity benefits.