Karl Ehrenfels
Senior Design Assurance Engineer, Smiths Medical
- Role
- Senior Design Assurance Engineer at Smiths Medical
- Location
- Bristol, CT, US
- LinkedIn followers
- 500 followers
About Karl Ehrenfels
Senior level Design-Quality Engineer experienced in Product Development, Risk Management and Medical Devices. Capable in Component, Product and Process Qualification, Design Verification and Validation, Design Control and Regulatory Compliance. Accountable, flexible problem solver in design and process validation, trouble shooting, and quality planning. Recognized skills and Team leadership in design, materials, testing, process control, non-conformance, Root Cause Analysis. Experienced user of CAD, Analytical, Statistical,Quality and Project Management tools. Inventor with 10+ patents.
Experience
Senior Design Assurance Engineer
Apr 2018 — Present
Education
University of New Haven
Bachelor of Science (B.S.)
Skills
- Design Verification
- Supplier Quality
- Iso 14971
- Root Cause Analysis
- Tolerance Analysis
- Gmp
- Injection Molding
- Ce Marking
- Iso 13485
- Iec 60601
- Design of Experiments
- Manufacturing
- Quality System
- V&V
- Process Validation
- Fmea
- Quality Planning
- Risk Management
- Iso14971
- Dmaic
- Manufacturing Engineering
- Capital Equipment
- Ppap
- Biomedical Engineering
- Design Validation
- Product Design
- Iso
- Fda
- Spc
- Kaizen
- Continuous Improvement
- 21 Cfr
- Design Control
- Surgical Instruments
- Quality Management
- Pfmea
- Lean Manufacturing
- Materials
- Solid Modeling
- Plastics
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