999 Main Street • Any Town, NY 99999 • 999-999-9999 • firstname.lastname@example.org
Product Development ~ Regulatory Submittals ~ Verification and Validation
product development engineer with experience bringing medical devices from concept stage to production. Project management background at a small start-up company, with the unique ability to perform multiple job functions, ranging from clinical support to quality assurance. Strong analytical and problem solving skills, and proficient in both Mechanical Desktop and Solidworks.
ABC Inc. Any Town, NY 2006 – Present
- As a biomedical engineer for ABC, Inc., serves as a member of the technical assessment and requirement analysis team (TARA).
- Manages numerous equipment modalities, including but not limited to endoscopic video systems, surgical microscopes, clinical information systems, and patient monitoring to include telemetry systems.
- Participates in involved technology assessment site visits to military medical treatment facilities executing equipment assessments and generating recommendations in accordance with equipment life cycle management guidelines.
- Addresses acquisition requirements on medical technologies from a service-wide standpoint arranging group buys as applicable for substantial cost savings whenever possible. Determines system integration issues during procurement phase of life cycle management.
XYZ Corp. Any Town, NY 2004-2006
- Responsible for developing measurement and analysis protocols as well as optimizing skin treatment protocols for assessing product benefits using non-invasive instrumentation.
- Investigate the fundamentals of skin using analytical instrumentation ATR-FTIR , NMR, confocal microscope, SEM and spectrophotometer.
- Perform DOEs to test hypothesis related to project outcomes.
- Conduct benchmarking clinical studies in accordance with SOPs using the optimized protocols.
- Analyze the data from the small scale studies to evaluate product benefits and consistently record experimental methods, materials and results in electronic laboratory notebooks and present scientific investigations at team meetings.
BCD Inc. Any Town, NY 2003 – 2004
- Statistical analysis expertise: clinical trial data analysis planning, execute data analysis and interpretation.
- Define analysis endpoints and statistical methodology for clinical trials. Routinely applied statistical methods including: data cleaning, plotting and visualization; correlation and linear regression, non-parametric analysis, student T-test, F-test, ANOVA, ANCOVA, hypothesis testing, parameter estimation, sample size calculation, multivariate analysis, generalized linear models, logistic regression, and design of experiments (DOE).
- Regulatory Data reporting and regulatory document submission.
- Participate in medical device software development team, validation expertise, and management of data output streams.
- Medical Information Specialist, perform routine medical database searching for current medical device medical literature for medical affairs and medical education.
- in Sales Field Team training programs for medical device data output reporting and annotation programs.
New York University New York, NY
o Masters of Science in Bioengineering, 2008
University of New York New York, NY
o Bachelor of Science in Biological Engineering, Minor in Biomechanics, 2004