Sr. Manufacturing Technician, Sr. Assembly Tech Medical Devices

Job Description

About Q’Apel:

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

In the few short years since our first commercial launch, we have grown rapidly. Our products are recognized for their superior quality and novel design, and we have recently expanded into Europe and beyond.

Successful Q’Apel team members step up to the plate and work together to achieve our goals every single day. Our philosophy, formed from our earliest days as a startup, encourages an all-hands-on-deck attitude, taking on all challenges with excitement and creativity.

Position Responsibilities and Authorities:

Supports production needs as scheduled.

Continuous and prolonged utilization of the microscope on a daily basis.

Continuous and prolonged utilization of the calipers, rulers, snap gauges, tappi charts, leak testing, and vision systems on a daily basis is required.

Performs medical device manufacturing inspection and testing of products to ensure they meet specifications

Maintains legible and accurate records.

Assists medical device 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.

Solves most problems or issues that arise; uses experience to forward company goals.

Adhere to the safety requirements of medical device manufacturing processes, equipment, and materials

Daily and prolonged use of a microscope to inspect the Catheter for any defects and damage

Assemble and inspect commercially available fiber-based balloons and catheters.

Perform visual and regulatory inspections to ensure product quality

Cross-train new team members

Utilize small hand tools, calibrated instruments, measurement equipment, etc.

Other duties as requested.

Qualification Requirements:

Education:

High School diploma

Skills and Experience:

5+ years of catheter manufacturing assembly experience or medical device equivalent (required for this position)

Has most skills developed for catheter production.

Good manual dexterity and visual acuity

Manufacturing Environment

Evaluate manufacturing processes and equipment

Document activities for production records and manufacturing equipment

Perform troubleshooting processes for manufacturing operations

Prepare written manufacturing processes documentation

Write manufacturing processes and procedures for use on the manufacturing floor

Improve quality and manufacturing issues

Support manufacturing on quality-related problems

Operate manufacturing and assembly equipment necessary for production within a clean room environment

Follow through with the manufacturing procedures

Effective communication skills (both written and verbal) are required.

Ability to work independently or in a team setting.

Is organized and self-motivated

Experience working in a regulated industry (medical device development experience required along with a solid working knowledge of FDA Quality System Regulations and ISO 13485)

Experience working in a controlled environment room (CER) (required for this position)

Knowledge and exposure to applicable regulations (QSR, MDD, CMDR, and ISO) (required for this position)

Experienced microscope user (required for this position)

Expert Hotbox user with a solid understanding of the airflow, temperature, and calibration requirements (required for this position)

Proficient at balloon bonding, tipping, distal, etc. (required for this position)

Benefits:

Competitive compensation and stock options

Medical (HMO & PPO Options)

Dental

Vision

Basic Life AD&D

Disability Benefits

Employee Assistance Program (EAP)

Worldwide Travel Assistance

Pet Insurance

Legal Plan

Flexible Spending Account (FSA)

Paid Vacation and Holidays

Short Term Disability

Long Term Disability

401K

Company Events & big milestones celebrations

Daily Complimentary Coffee, beverages, fruits, and a variety of snacks

Q'apel is an equal-opportunity employer. All aspects of employment including the decision to hire will be based on merit, competence, performance, and business needs.

The anticipated compensation range for candidates who will work in Fremont, California is $30.00 per hour to $39.00 per hour + equity +benefits. Our 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 considering 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 compensation. Q’Apel is a multi-state employer, and this compensation range may not reflect positions that work in other states.

Monday - Friday, Sometimes Weekends

Shift Start Time: 8:00 AM

Shift End Time: 5:00 PM

Non-Exempt/Hourly Position

Opportunities for overtime available

Onsite