Diego W. Lentz
Biomedical Engineer, Cardiac rhythm management
Minneapolis, MN · (612) 555 0131 · name@example.com · linkedin.com/in/diegowlentz
Key Qualifications
EXPERIENCE
Six years in cardiac device research and development
INDUSTRIES
Cardiac rhythm management, implantable devices
SPECIALTIES
Design controls, design history files, risk management, submission support
SYSTEMS
SolidWorks, MATLAB, Minitab, Windchill, LabVIEW
CREDENTIALS
Fundamentals of Engineering examination passed; member, Biomedical Engineering Society
EDUCATION
Master of Science in biomedical engineering, University of Minnesota
Executive Summary
Biomedical engineer with six years in cardiac rhythm devices, working under design controls from concept through submission. Owns design history files, writes risk analysis under the international standard 14971 and has carried two products through 510k premarket notification with the Food and Drug Administration.
Signature Achievements
- Carried a lead delivery accessory from concept to 510k clearance in fourteen months.
- Closed a design history file gap review across three legacy products before an agency inspection.
- Cut bench test time on a catheter tip by half by redesigning the fixture and sample holder.
- Reduced risk file review comments from twenty six to four between the first and second submissions.
- Ran the biocompatibility test plan that cleared a new polymer for patient contact.
- Trained nine engineers on writing design inputs that can actually be verified.
Professional Experience
Biomedical Engineer
Cedar Lake Cardiac Systems, Minneapolis, MN 2022 to present
Research and development group of twenty two working on implantable leads and delivery tools
- Owns design inputs, outputs and traceability for two active projects under design controls.
- Writes and maintains the risk management file under the international standard 14971.
- Runs bench verification on tensile, fatigue and dimensional characteristics of components.
- Prepares design sections of 510k premarket notification submissions with regulatory affairs.
Associate Design Engineer
Nicollet Medical Devices, Saint Paul, MN 2020 to 2022
Development team of nine at a supplier of single use surgical instruments
- Modeled instrument parts in SolidWorks and released drawings for tooling.
- Built and tested prototypes for surgeon evaluation sessions.
Research Assistant
University of Minnesota, Minneapolis, MN 2019 to 2020
Cardiovascular laboratory studying flow through prosthetic valves
- Ran flow loop experiments and processed pressure data in MATLAB.
- Coauthored a conference paper on valve leaflet motion.
Licensure and Certification
Fundamentals of Engineering examination passed, Minnesota
Member, Biomedical Engineering Society
Education
Master of Science in biomedical engineering, University of Minnesota
Bachelor of Science in mechanical engineering, Iowa State University
Core Skills
Design controls · Design history files · Risk management · Bench verification · SolidWorks · Minitab · MATLAB · Biocompatibility planning · Submission support · Technical writing