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Sr. Process Development Engineer

Shifamed
  • Los Gatos, California
    21 days ago

    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.
     
    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:
     
    Akura Medical, a Shifamed portfolio company, is seeking a highly skilled and motivated Senior Process Development Engineer.
    This position will help design and develop processes for catheter, nitinol and console manufacturing. You will be responsible for hands-on design, development, and manufacturability of the company’s products including specific products, subassemblies, and components. You will be directly involved in development and problem-solving in a wide range of areas including assembling handling methods, component manufacturing, process optimization, equipment selection and operation and verification & validation activities.
     
    Responsibilities, Skills & Hands-On Experience:
    • Provide creative solutions to satisfy unmet clinical needs through creation of innovative processes and methods of manufacture.
    • Work as part of a cross-functional team to develop, optimize, verify, and validate processes through bench, in-vitro, and in-vivo testing.
    • Effectively document work throughout the development process inclusive of lab notebooks, design reviews, manufacturing process instructions (MPIs), equipment qualifications, and process validation.
    • Research, develop, modify and test manufacturing methods and equipment; perform IQ/OQ/PQ validations and gauge R&R.
    • Drive and provide support to quality processes and applying formal problem-solving techniques to determine root cause, and implementing solutions (non-conformance, CAPA, change management, audits, product complaint investigations, etc.).
    • Design, execute, and analyse experiments using sound statistical methodology.
    • Participate in risk management activities, including development and ownership of process FMEAs.
    • Support product verification and validation activities by developing test protocols and writing test reports.
    • Select and manage critical suppliers and vendors.
    • Provide technical support for regulatory/clinical, marketing, and/or sales efforts
    Education & Work Experience: 
    • Bachelor's, or Master's, degree in an Engineering discipline. 
    • 5-8 years of medical device industry experience.
    • Experience with design for manufacturing and process development for stent manufacturing (laser cutting, shape setting, microblasting, electropolishing).
    • Experience with design and fabrication of assembly fixtures.
    • Tool and fixture design on Solidworks or equivalent Lab and clean room environment exposure.
    • Excellent communication skills, ability to work independently or in project team setting.
    • Experience with Nitinol material properties and processing Catheter manufacturing (braiding, lamination, tip forming, thermal bonds)
    • Process ownership from concept to commercialization Lean manufacturing/Six Sigma
    • Experience working under quality systems designed to meet governmental regulations.
    • Familiarity with FDA QSR, ISO 13485.
    • Must be proficient in Solidworks/CAD Comfortable working in a clean room environment.
    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 $130,000 to $160,000 + 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 hr@shifamed.com.

    Numbers & Facts

    LocationLos Gatos, California
    Websitehttps://www.shifamed.com/careers/

    Skills

    • 3D Modelingunmatched
    • Analysis Skillsunmatched
    • Auditingunmatched
    • Bond Marketunmatched
    • CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing)unmatched
    • Cardiologyunmatched
    • Cardiovascular Diseaseunmatched
    • Catheterizationunmatched
    • Change Managementunmatched
    • Cleanroomunmatched
    • Communication Skillsunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Cross-Functionalunmatched
    • Entrepreneurshipunmatched
    • Equipment Selectionunmatched
    • FDA (Food and Drug Administration)unmatched
    • Government Regulationsunmatched
    • IDE (Integrated Development Environment)unmatched
    • ISO (International Organization for Standardization)unmatched
    • In Vivo Testingunmatched
    • Internet Applicationunmatched
    • Interviewing Skillsunmatched
    • Laboratory Notebookunmatched
    • Lean Manufacturingunmatched
    • Lean Six Sigmaunmatched
    • Manufacturingunmatched
    • Manufacturing Designunmatched
    • Manufacturing Methodsunmatched
    • Manufacturing/Industrial Processesunmatched
    • Manufacturing/Production Testingunmatched
    • Marketingunmatched
    • Medical Equipmentunmatched
    • Medical Productsunmatched
    • Mobile Applicationsunmatched
    • Online Chatunmatched
    • Ophthalmologyunmatched
    • Problem Solving Skillsunmatched
    • Process Developmentunmatched
    • Process Engineeringunmatched
    • Process Improvementunmatched
    • Process Validationunmatched
    • Product Developmentunmatched
    • Product Supportunmatched
    • Product Testingunmatched
    • Quality Assurance Methodologyunmatched
    • Quality System Requirements (QSR)unmatched
    • Regulationsunmatched
    • Reporting Skillsunmatched
    • Research & Development (R&D)unmatched
    • Risk Managementunmatched
    • Root Cause Analysisunmatched
    • Salesunmatched
    • SolidWorksunmatched
    • Technical Supportunmatched
    • Test Plan/Scheduleunmatched
    • Validation Testingunmatched
    • Vendor/Supplier Managementunmatched
    • Writing Skillsunmatched

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