Committed, results-oriented engineer with 8 years of experience in the medical device industry working with cross-functional teams and external suppliers to realize best of class products that fill market voids, customers' needs and improve patient outcomes. Seeking opportunities in a more customer facing role, sales.
Creative problem solver
Intimate knowledge of products; LigaSure, EndoGIA, AbsorbaTack, Versaport, Sonicision
Calm in high pressure situations
Ability to learn on the fly, adaptable
MITG WLA (Women's Leadership Association)
Volunteer at Yale New Hospital 2012-2013
Demonstrated ability to meet goals:Fastest product launch, Gold 2; 14 months from Concept entry to Launch
Client Interface:Attend OR cases to support product launches, gain insight for new projects and as necessary. Engage surgeons, PACE, Medical Affairs, nurses and OR techs throughout the product development process for feedback. Shadowed sales trainings.
Covidien team Product Innovation Award: Radial Reload
Direct customer service and sales experience: Banana Republic and Victoria's Secret retail sales part time 2005-2008.
SENIOR DESIGN QUALITY ENGINEERMar 2014 to Current MEDTRONIC - Boulder, CO
Managed and completed Quality deliverables for the Gold 2 project while learning new procedures and a new COT. Supported launch according schedule resulting in the shortest project Concept entry to Commercialization exit timeframe (14 months) for LigaSure.
Helped draft supporting documents and answer FDA questions resulting in acceptance of the 510k for Sonicision special indication claim for ENT procedures.
Gathered consensus and driving initiative to streamline processes for Receiving Inspection
Support project Hook, Lead project Einstein
SENIOR DESIGN QUALITY ENGINEERJun 2013 to Mar 2014 COVIDIEN - North Haven, CT
Lead all quality activities for projects such as AST, Radial Reload and GSP, Eichler (ports).
Help translate VOC into technical product specifications
Analyze complaints related to predicate and competitive devices for input into risk management and design of new, better products
Draft risk management documents incorporating feedback and input from team members and clinicians for approvals.
Generate usability protocols and reports. Participate in Usability labs.
Work with and manage qualification activities for components at various suppliers.
Visit vendor sites to assess their ability to produce components within established specifications.
Facilitate cross-functional teams, building consensus and support for positive change and shared goals.
Provide inputs to IFUs and User Guides through Risk Management and Product Verification and Validation outputs.
Support product launches. Attend OR cases for first human uses and as needed.
Draft, review and revise protocols related to Assembly Line Validations and MSAs. Facilitate PFMEA activities to proactively build quality into manufacturing lines.
DESIGN QUALITY ENGINEER IIJun 2008 to May 2013 Covidien - North Haven, CT
Led, managed, completed all Quality deliverables for AST products through the product development lifecycle.
Key project; Radial Reload
INTERN, Complaints InvestigationsJan 2007 to Jan 2016 U.S. Surgical - North Haven, CT
LAB ASSISTANTJan 2006 to Jan 2016 YALE UNIVERSITY - New Haven, CT
Supported research relating to various conjugations of nanoparticles for drug therapy to target brain tumors during in vivo testing phases.
Supported research for drug therapy development targeted towards treating depression.
RESEARCH ASSISTANTOct 2005 to May 2007 UCONN - Storrs, CT
Bachelor of Science, BIOMEDICAL ENGINEERING2007UNIVERSITY OF CONNECTICUT - Storrs, CTBIOMEDICAL ENGINEERING
ASQ-CQE Certified; DFSS Green Belt; RABQSA
AGILE, BPCS, Design of Experiments, Microsoft Office, Minitab, MSA, new product development, OQ, PQ, research, Risk Management, Statistical Analysis, Validation