Validation Engineer

This is a six-month contract position with the potential opportunity to convert to full-time employment. You will be responsible for all aspects of process validation with the expectation of achieving regulatory (FDA/ISO) compliance and audit readiness. This is an on-site position and will require reporting to our offices located in Los Gatos, CA. Base pay range $80.00/hr - $100.00/hr Organization : Akura Medical, a Shifamed Portfolio Company About Shifamed Shifamed LLC is a privately held medical device innovation hub focused on cardiology and ophthalmology product development. Description Akura Medical focuses on addressing major challenges of venous thromboembolism (VTE) with a differentiated approach and recently announced the first-in-human use of its mechanical thrombectomy platform. For more information, visit www.akuramed.com. Responsibilities, Skills & Hands-On Experience Stays current with FDA, ISO, GHTF etc. guidance documents pertaining to process validation. Exceptionally strong documentation skills for plans, protocols, reports, and risk documents with an understanding of FDA expectations. Full ownership of Process Validation Master Plan/Report/Matrix, IQ/OQ/PQ/PPQ protocols/reports, PFMEA, Monitoring Plan and Report including monitoring of inputs/outputs and control charts. Documentation of DOE to justify process parameters in the OQ. Perform physical testing using Instron, Mark 10, Micro-Vu, and other required equipment. Knowledgeable with catheter, sheath, dilator medical device manufacturing processes (adhesive bonding, UV cure adhesives, pouch sealing, 3-D printing, braiding, laminating, electromechanical assembly, thermoforming, etc.). Experience with electromechanical box build of capital equipment. Experience working with suppliers on process validation (laser welding, injection molding, insert/over molding, luer bonding, etc.) and monitoring of validated processes. Attribute and Variable Test Method Validation. Statistics knowledge and sample size determination; document rationale in protocols. Project management skills (Gantt charts, task lists, meeting facilitation). Problem-solving skills (A3, Six Sigma DMAIC). Familiarity with Facility Validation, Packaging Validation, Sterilization Validation, eQMS Validation, Netsuite/ERP/CRM Validation. Education & Work Experience Bachelor’s or master’s degree in engineering. 7+ years of medical device industry experience. Previous experience in medical device development. Experience with quality systems meeting regulatory requirements (FDA QSR, ISO 13485). Strong verbal and written communication skills. Excellent attention to detail and adaptability. Strong problem-solving abilities and diagnostic skills. Comfortable working in a clean room environment. Experience in a startup environment. Additional details Our salary ranges are calculated by role, level, and location. The base hourly pay range for this contract position is between $80 - $100 per hour. This role is in Mountain View, CA, with other location references shown for context. Seniority level Mid-Senior level Employment type Contract Job function / Industries Industries: Medical Device Join Our MedTech Talent Pool – Engineers, Scientists, Clinical, and R&D Experts We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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