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Medical Device Assembler- Catheter

PENTAX Medical
Redwood, CA Full Time
POSTED ON 12/31/2024 CLOSED ON 2/3/2025

What are the responsibilities and job description for the Medical Device Assembler- Catheter position at PENTAX Medical?

About PENTAX Medical 
Our mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. Through leading edge R&D and manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community. 
 
Position Opening: 
Medical Device Assembler- Catheter

 Why JOIN Us? 
We are an established medical device leader that is preparing for high growth. This means that PENTAX is looking to invest in its team and provide a collaborative and encouraging work environment.   

PENTAX Medical is proud of its comprehensive benefits program and generous Paid Time Off and Holiday policy.   

 Want More INFO?
This individual is responsible for assembling the CryoBalloon product line, both the current and next generation.

Responsibilities of Medical Device Assembler- Catheter:
· Perform all builds and testing for CryoBalloon Ablation Handle and/or Catheter
· Perform "In Process" inspections as needed
· Report any concerns and/or issues to manufacturing engineer, Production Lead, or supervisor
· Adhere to quality standards regarding operations, process, and policy as defined by Pentax and FDA regulations
· Ensure Clean Room environment that requires routine cleaning of work area as required by Pentax and FDA regulations
· Assist with inventory counting in introduction area and/or warehouse
· Perform other necessary duties as assigned by manufacturing engineer, Production Lead, or supervisor
· Perform sterilization validation and re-validation

Requirements of Medical Device Assembler- Catheter:
· Must possess basic production, testing and inspecting skills relevant to the medical device industry, including knowledge in use of the different measuring equipment (i.e. microscopes. calipers, micrometers. scales).
· Attention to detail and product knowledge
· Ability to read and follow work instructions and drawings.
· Ability to use electronic systems and MS office (i.e. Word, Excel).
· Previous experience working in quality management systems, functioning within FDA regulations.
· Must operate with great attention to detail and work in accordance with all quality, regulatory and safety requirements

It is the ongoing policy and practice of PENTAX Medical to provide equal opportunity in employment to all employees and applicants. No person shall be discriminated against in any condition of employment because of age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. 

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