| 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 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. Responsibilities, Skills & Hands-On Experience - Stays current with FDA, ISO, GHTF etc. guidance documents pertaining to process validation.
- Exceptionally strong documentation skills of plans, protocols, reports risk documents with savvy knowing what the FDA expects and not over or under doing it.
- Full ownership of Process Validation Master Plan/Report/Matrix, IQ/OQ/PQ/PPQ protocols/reports, PFMEA, Monitoring Plan and Report which includes matrix detailing monitoring of inputs, outputs, control charts, etc.
- Documentation of DOE to justify process parameters in the OQ and referenced in the OQ.
- Perform physical testing using Instron, Mark 10, Micro-Vu, and other test equipment as required.
- Knowledgeable with catheter, sheath, dilator medical device manufacturing processes such as adhesive bonding, UV cure adhesives, pouch sealing, 3-D Printing, braiding, laminating, electromechanical assembly, thermoforming, hotbox processes using shrink tube, laser cutting, laser welding, shape setting, etch, electropolish, plasma treatment, etc.
- Knowledgeable with electromechanical box build of capital equipment.
- Experience working with suppliers regarding process validation of processes performed at suppliers such as laser welding, injection molding, insert/over molding, luer bonding, etc., and associated monitoring of validated processes.
- Attribute and Variable Test Method Validation.
- Knowledgeable with statistics and sample size determination, and documenting sample size rationale in protocols.
- Project management skills, use of Gannt charts, task lists, efficient chair of meetings.
- Problem solving skills such as A3, Six Sigma DMAIC.
- Familiarity with the following: Facility Validation/CER/Pest Control, 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 working with medical device development.
- Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485.
- Effective verbal and written communication skills.
- Excellent attention to detail, flexible, and adaptable to change.
- Must have excellent problem-solving skills, ability to diagnose issues, find and test solutions.
- Comfortable working in a clean room environment.
- Previous experience working in a startup 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 hourly pay range for this contract position is between $80 - $100 per hour.
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.
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