Sr. Assembler

Shifamed•Los Gatos, CA

6d•$32 - $35

About The Position

Akura Medical, a Shifamed Portfolio Company, is focused on a differentiated approach delivering an effective solution to address the major challenges of venous thromboembolism (VTE). Akura recently announced the first-in-human use of its mechanical thrombectomy platform. Each year VTE affects as many as 900,000 Americans, resulting in about 100,000 premature deaths. 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.

Requirements

High School diploma or equivalent, preferred.
Minimum 4 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 work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other employees and supervisor.

Nice To Haves

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

Responsibilities

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.