Manufacturing Technician, Assembly Technician 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.

Job Description Summary:

Responsible for the assembly of medical devices such as neurovascular catheters.

Position Responsibilities and Authorities:

• Daily assembly of medical devices in the controlled environment room (CER) is required.
• 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 daily manufacturing inspection and testing of products to ensure they meet specifications and FDA requirements required.
• Maintaining legible and accurate records is required.
• Daily communication with the manufacturing team members, engineers, supervisors, and management (both written and verbal) is required for this position.
• 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.
• Solid knowledge, understanding, and exposure to regulations such as QSR, MDD, CDR, and ISO are expected.
• Other duties as requested.

Qualification Requirements:

Education:

High School Diploma

Experience & Skills:

• Minimum of 2-3 years of neurovascular catheter manufacturing experience or medical device assembly equivalent experience
• Good manual dexterity and visual acuity
• 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 preferred along with a solid working knowledge of FDA Quality System Regulations and ISO 13485) is a plus
• Experience working in a controlled environment room (CER) is a plus
• Knowledge and exposure to applicable regulations (QSR, MDD, CMDR, and ISO a plus)

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 $26.00 per hour to $30.00 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.