Jenna N. Shaw
OBJECTIVE
Obtain a position in the medical device industry where I can utilize my skills as a biomedical engineer in the design and manufacturing of implantable medical devices for the global market.
EDUCATION
University of Minnesota-Twin Cities, Institute of Technology Minneapolis, MN
Bachelor of Biomedical Engineering, May 2009
Minor in Mathematics
Cumulative GPA 3.536
Technical GPA 3.570
Emphasis Area: Biomechanics - Tissue Mechanics and Biomaterials
Relevant Coursework: Bioelectricity and Bioinstrumentation, Biomechanics, Biomedical Engineering: Cell and Molecular Biology, Biomedical Engineering: MatLab Programming, Physiology, Biomaterials, Biomedical Transport Processes, Tissue Engineering, Tissue Mechanics, Quality Engineering and Reliability
SKILLS
Instrumentation: Differential Scanning Calorimetry, Dynamic Mechanical Analysis, MTS Material Testing System, Capillary Rheometry, Scanning Electron Microscopy, Energy Dispersive Spectroscopy
Computer Skills: Proficient in Microsoft Applications, MatLab, Mathematica, Minitab, Windchill/PDM, SAP
RELEVANT
EXPERIENCE
Medtronic- Neuromodulation Fridley, MN
Manufacturing Engineer 7/2010 - Present
• Provide development and production support for a catheter manufacturing line transitioning from product development to commercial release
• Collaborate with mechanical design engineers on Voice of the Customer, Voice of the Business and Concept Engineering.
• Lead strategy development and execution for manufacturing issue resolution with design, supply chain, and quality organizations.
• Perform process validation activities including requirement development, test method development/ qualification, operational qualification and validation.
• Selected process owner by management for Operational and Performance Qualification deliverables for the Neuromodulation Operations organization.
Quality Engineer – Rotational 7/2010 - Present
• Released Product Reliability
- Assessed class III implantable medical device risk via Health Hazard Analysis for product non-conformance associated with Corrective and Preventative Actions (CAPA). Presented to the Risk Evaluation Board (REB) the product non-conformance issue, engineering evaluation, effect on patient safety, and the Health Hazard Analysis results.
- Evaluated product reliability and associated patient risk assessment in regards to supplier, manufacturing, and released system design changed.
• Strategic Reliability/ Failure Analysis
- Determine root cause through failure analysis techniques for device failures occurring in design verification testing, returned product analysis, or other testing failures. Use of analytical techniques such as Scanning Electron Microscopy and Electron Dispersive Spectroscopy.
- Developing use-condition models via MatLab programming to be used in the development of new products in order to improve design for reliability.
- Perform exploratory analysis on class III implantable medical devices as part of a long-term life test in order to establish and confirm the reliability profile of the devices.
Associate Quality Engineer- Rotational 6/2009 – 6/2010
• Manufacturing Quality
- Managed and facilitated a team of cross-functional engineers in the completion of thirteen process Failure Mode and Effects Analysis (pFMEA).
- Provided support to the Laser Etch manufacturing processes as well as facilitated negotiations with other Medtronic Business units in regards Intra- Company Quality Agreements.
• Supply Chain Quality – Component Development
- Collaborated with a supplier on the development and approval of component control plans.
- Lead a team of engineers in a design clarification project to improve the manufacturability of a class III implantable medical device. The project entailed supplier selection, design of inspection gauging, Measurement System Analysis, component qualification, and collaboration with Regulatory Affairs on a Pre-Market Approval (PMA) supplement.
St. Jude Medical Minnetonka, MN
Quality Engineering Intern-CVD 5/2008 - 9/2008
• Identified the Test Methods utilized during Manufacturing Inspections, wrote Test Method Validation/ Inspection Validation protocols and conducted required testing
• Created a Quality Assurance Technician Training Module consisting of Quality Concepts, Measurement Tools and Techniques, Lean Production Concepts, and Statistics
• Performed a shelf life study on resin used in extrusion and molded components
3M St. Paul, MN
Technical Aide ...
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