Medical Device Assembler
3 weeks ago
At Q'Apel, we are passionate about revolutionizing neurovascular access. In the simplest sense, we design solutions for vascular interventions and unmet clinical needs. Our team is dedicated to creating technology that delivers in emergency situations. We value collaboration and teamwork to achieve our goals daily. We offer a dynamic environment with a startup philosophy, requiring an all-hands-on-deck attitude and excitement for change.
We are seeking an experienced Manufacturing Technician II to assemble Neurovascular Medical Devices as a Catheter Assembler. The successful candidate will be responsible for manually assembling neurovascular catheters and maintaining efficient production line needs. The ideal candidate will have a strong background in manual dexterity, visual acuity, and effective communication skills.
Responsibilities:
- 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)
- 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
Requirements:
- 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
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
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