Senior Manufacturing Technician (Catheter Medical Devices) - QAPEL MEDICAL INC

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 Title: Senior Manufacturing Technician (4 new open positions, direct hire)

Job Function: Assembly Technician for Neurovascular Catheter Medical Devices

Job Location:Q’Apel Medical Inc. 4245 Technology Drive, Fremont CA 94538

All Applicants:Please submit applications online. Walk-in resumes and applications will not be accepted. We're looking for a candidate with a minimum of 5 years of Neurovascular Medical Device experience.

Job Description Summary:

Responsible for the senior-level assembly of the medical devices Neurovascular Catheters and direct support in maintaining efficient, timely, and cost-effective production line needs

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 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

Values and Diversity:

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.

Our salary 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 base salary.