Assembler

*Mavericks Endo, Inc.
* *JOB DESCRIPTION* *GENERAL INFORMATION* *Position Title: *Assembler *Department: *Operations *Reports to: *Director, Operations *FLSA Status: *Non-Exempt *DESCRIPTION* Mavericks Endo is a medical device start-up created out of The Foundry, a MedTech incubator with a long track record of bringing medical device innovations to market.
Mavericks Endo is developing a cardiovascular implant to be delivered by a catheter to address significant unmet clinical needs.
Mavericks Endo is seeking an Assembler to join a small and dynamic group to manufacture and develop novel cardiovascular implants and delivery systems.
*MAJOR DUTIES AND RESPONSIBILITIES* * Assembling all implant and delivery systems to support all Verification and Validation activities as well as clinical studies.
Some of these assembly responsibilities will require working under microscope at magnifications ranging from 4X-12x.
* Utilizing small hand tools, tweezers, razor blades, UV cure stations, hot boxes, and pouch sealers to assemble product in a controlled manner.
* Ability to read and interpret all manufacturing process instructions, engineering drawings, and inspection procedures.
* All documents will be written in English.
* Willing to work in a clean room environment adhering to proper gowning procedures and material controls.
* Maintain a clean and orderly work area.
* Demonstrate accuracy, thoroughness and monitor all work to ensure quality product.
* Train new operators on existing production processes as needed.
* Ability to work with engineers to identify and communicate any process improvements with engineering teams.
* Support company goals and objectives, policies and procedures, ISO, and FDA regulations * Perform other duties as assigned.
*PREFERRED QUALIFICATIONS* *Education and/or Job Experience*: * High school diploma / GED is required.
* Experience in the medical device industry, particularly with endovascular graft implants (fabric and metal based) and delivery catheters, is strongly preferred.
*Special Skills, Abilities, and Requirements*: * Excellent level of hand-eye coordination and manual dexterity to work with small components in a controlled manufacturing setting.
* Experience working in CER and basic knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practice (GDP).
* Experience with UV adhesive bonding and thermal bonding processes.
* Working knowledge of Microsoft Office (e.
g.
, Word, Excel, PowerPoint) or similar software for document creation, data analysis, and presentations * Ability to demonstrate exceptional teamwork on smaller teams with aggressive goals.
* Good communication skills.
Job Type: Full-time Pay: $34.
00 - $37.
00 per hour Benefits: * 401(k) * Dental insurance * Flexible spending account * Health insurance * Paid time off * Vision insurance Schedule: * 8 hour shift * Overtime * Weekends as needed Supplemental pay types: * Overtime pay Work Location: In person