Quality Technician

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.

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: The Quality Technician is responsible for performing quality inspections and testing under limited supervision in accordance with company procedures.

Responsibilities, Skills & Hands-On Experience: Perform in-process and final labeling and packaging inspections according to test methods and quality specifications. Perform incoming inspection of purchased components and subassemblies according to specifications, including First Article Inspections. Generate detailed and accurate inspection and testing records in accordance with Good Documentation Practices (GDP) and company Quality Management System requirements.

Maintain and operate inspection and test equipment. Support the Engineering team with projects, as needed, including performing design verification and process validation testing. Ensures traceability of components and products is maintained at inspection points. Perform other duties as assigned.

Preferred Skills

& Hands-On Experience: Must have excellent hand/eye coordination, manual dexterity, and vision corrected to 20/20. Must have attention to detail and be able to document inspection results clearly and accurately. Experience using vision measurement system, Micro. Vu preferred. Proficient use of common measuring equipment, such as microscopes, calipers, micrometer, snap gauge, pin gauges, rulers, etc.

Experience using tensile testers preferred. Maintain records of inspection within Akura’s eQMS system. Proficient with computer software such as Excel and Word. Excellent communication skills required (verbal and written). Ability to read English and comprehend verbal and written instructions. Ability to read and interpret engineering drawings preferred.

Ability to use microscope for extended periods of time. Ability to wear protective garments such as a lab coat, shoe covers, hair covers, and gloves.

Education

& Work Experience: High School Diploma required. Minimum of 3 years of experience performing inspections; medical device industry experience preferred. 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.

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 hr@shifamed.com.