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Posted 11h ago

Sr. Assembler

@ Akura Medical
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Los Gatos, California, United States
$62k-$70k/yrOnsiteFull Time
Responsibilities:assembling components, performing checks, maintaining cleanroom
Requirements Summary:7+ years medical device assembly experience, ability to perform precision measurements and soldering, cleanroom gowning, follow GMP/SOP/FDA procedures, strong English, basic math, and quality inspection skills.
Technical Tools Mentioned:pin gauges, digital calipers, snap gauges, digital micrometers, microscopes, test fixtures, hot boxes, UV cure stations, laminators, braiding machines, soldering stations, 3D printing, electropolishing, laser welding, laser cutting, leak testing
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Job Description
Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE), which affects up to 900,000 Americans each year. The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana™ Thrombectomy System in acute pulmonary embolism patients. In parallel, Akura Medical is developing NavIQ™, a software platform that transforms CT angiograms into 3D pulmonary vascular models to enhance visualization, procedural planning, and clot assessment towards better safety, efficacy, and ease of use. Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&D and manufacturing center in Doha, Qatar. To learn more about Akura Medical, please visit www.akuramed.com.
 
ABOUT SHIFAMED
Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.
 
Description:


Performs a variety of mechanical prototype, sub-assemblies, final assemblies and finished device. Works from diagrams, drawings, work instructions, SOPs and in accordance with GMP regulations.  Makes continuity checks on work in process and completed.  Brings abnormalities to the attention of supervisors in a timely manner. May conduct quality inspections on processing line in accordance with quality specifications.


Responsibilities, Skills & Hands-On Experience:
  • Assemble components into medical devices (catheters, consoles, accessories) in accordance with approved manufacturing procedures.
  • Utilize small hand tools, calibrated instruments, measurement equipment, microscopes, and test fixtures.
  • Perform in-process quality checks on sub-assemblies and finished product.
  • Work with engineers and technicians to resolve line issues and suggest improvements.
  • Maintain cleanroom integrity via proper gowning techniques and adherence to cleanroom environment practices and procedures.
  • Complies with Standard Operating Procedure requirements. Meets quality standards and performs basic measurements.
  • Completes documentation in an accurate and comprehensive manner Adhere to general safety rules, manufacturing procedures, company policies and procedures and FDA regulations.
  • Maintains a clean and organized work area.
  • Performs duties in a safe manner while adhering to safety policies.
  • Cross-train new team members.
Education & Work Experience:
  • High School diploma or equivalent, preferred.
  • Minimum 7 years of experience in medical device industry. 
  • Ability to read and write and English.
  • Ability to utilize basic math skills.
  • Ability to use pin gauges, digital calipers, snap gauges, digital micrometers and be able to determine Min Max of dimensions.
  • Ability to solder wires and small parts is a plus.
  • Familiarity with or experience with hot boxes, UV cure stations, laminators, braiding machines, soldering stations, 3D printing, electropolishing, laser welding, laser cutting, and/or leaking testing is a plus.
  • Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other employees and supervisor.
Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications. The base salary range for this full-time position is between $62,000 to $70,000 + equity + benefits.

 

NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to [email protected].