Mohamed Khaldi
Sr. Manager Engineering at AmgenMedical Devices Development | Combination Products | Pharma | GMP manufacturing
- Role
- Sr Manager Engineering at Amgen
- Location
- Los Angeles, CA, US
- LinkedIn followers
- 500 followers
About Mohamed Khaldi
Accomplished executive engineer with more than 18-years of experience in building successful teams and launching new products. Highly skilled in developing programs from conceptualization to commercial launch in medical devices or pharmaceutical industries. Expertise in combination products, drug eluding stents, long term neuromodulation, infusion pumps, PFS, autoinjectors, wearable electromechanical devices and surgical devices. Successful track record in bringing these products forward into clinical trials and the marketplace. Effective in both large multinational and start-up new venture leadership roles. Adept in building and leading successful teams and strategy execution. Approaches projects with entrepreneurial ambition to drive innovation and efficiency through exploration of process, technology and capacity improvement opportunities
Experience
Sr Manager Engineering
Aug 2016 — Present · Thousand Oaks, CA, US
Commercialization final BioTech and Drug ProductCombination productPrimary containerLife Cycle ManagementsProcess ImprovementCAPA, DV and validation of new processesElectroMechanicaL drug delivery devicesWearable platformFDA 21CFR810, MDR, EU, QMS, ISO 9001Manage successful large teamDrug deliver, PFS and AutoinjectorsDesign and development new product
Education
Rensselaer Polytechnic Institute
Bachelor's Degree, Mechanical Engineering
1996 — 2000
Rensselaer Polytechnic Institute
Master's Degree, Mechanical Enginnering
2000 — 2002
Skills
- Arabic
- Team Leadership
- Iso 13485
- Team Management
- Excel
- Pro/Engineer
- Automation
- Fda
- Microsoft Office
- Corporate Finance
- Validation
- Intellectual Property
- Pmp
- Design for Manufacturing
- Failure Mode and Effects Analysis (Fmea)
- Quality System
- Quality Systems
- V&V
- Process Simulation
- French
- Start-Ups
- Mechanical Engineering
- Word
- Design Control
- International Marketing
- Business Development
- Finite Element Analysis
- Fmea
- Team Building
- Cnc
- International Sales
- Product Development
- Process Development
- Strategic Planning
- Cross-Functional Team Leadership
- Nonprofit Technology
- Machining
- Iso 14971
- R&D
- Solidworks
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