Biomedical Engineer Resume Example (2026 Guide)
Biomedical Engineer resume example
A complete sample in the Modern template FitMyRole exports. The person and employers are fictional; the structure, skills and bullet style are what to copy.
Simone Seo
[email protected] • (555) 015-6620 • Minneapolis, MN • linkedin.com/in/simoneseo
Professional Summary
Biomedical Engineer with 3 years of experience in medical device R&D, working on Class II catheter and surgical instrument programs from prototyping through design verification. Has written and executed 40+ verification protocols under design controls and ISO 13485, and supported an FDA 510(k) submission from test planning to clearance. Works in SolidWorks and at the bench in equal measure, and uses Minitab to size samples and defend results. Partners with quality, regulatory and manufacturing so that designs are testable, buildable and documented the first time.
Technical Skills
- Medical Device Development: Design controls (21 CFR 820), design inputs and outputs, design history file, design reviews, traceability matrices, catheter design, prototyping
- Verification & Validation: V&V planning, test method development and validation, protocol and report writing, bench testing, tensile and burst testing, accelerated aging
- Regulatory & Quality: FDA 510(k), ISO 13485, ISO 14971 risk management, dFMEA, ISO 10993 biocompatibility, ASTM F1980, CAPA support
- CAD & Analysis: SolidWorks, GD&T, tolerance stack-ups, MATLAB, Minitab, gage R&R, ANSYS Mechanical
- Lab & Prototyping: Instron testing, 3D printing, fixture design, microscopy, laser welding, pilot builds
- Documentation Systems: Agile PLM, engineering change orders, Greenlight Guru, technical writing
Education & Certification
- Senior design: a low-cost pressure-sensing pad to warn of pressure injuries in wheelchair users, built and bench-tested with a clinical mentor.
- Engineer in Training (EIT) status in Minnesota.
Work Experience
Biomedical EngineerApril 2025 – PresentNorthstar Cardiac Devices, Maple Grove, MN
- Wrote and executed 22 design verification protocols for a Class II steerable catheter covering tensile, torque, burst and tip deflection, with 21 passing on first run.
- Supported the catheter’s FDA 510(k) submission, cleared in July 2026, by compiling test reports, traceability to design inputs and the biocompatibility summary, and drafting answers to an additional information request.
- Cut Instron fixture setup from 40 minutes to 10 by designing a quick-change grip fixture in SolidWorks and 3D printing the first versions for trial.
- Developed and validated 4 test methods, including a gage R&R study in Minitab that brought tip deflection measurement variation under 10% of tolerance.
- Updated the dFMEA and ISO 14971 risk management file after two design changes, adding 18 hazards traced to new verification tests.
- Built a sample-size worksheet that ties confidence and reliability levels to risk severity, which quality adopted for the next two programs.
- Report test status in weekly core team meetings with quality, regulatory and manufacturing, and carry action items through each design review.
Associate R&D EngineerJuly 2023 – March 2025Bluestem Surgical Instruments, Eden Prairie, MN
- Raised grip force of a laparoscopic grasper jaw by 25% across 6 SolidWorks prototype rounds while keeping it within the 5 mm trocar limit.
- Ran accelerated aging and seal strength testing on sterile barrier packaging to ASTM F1980 and F88, supporting a 3-year shelf life claim.
- Brought final assembly scrap from 8% to under 2% by working with the manufacturing engineer to rework a tolerance stack-up on the jaw pivot.
- Wrote 15 engineering change orders in Agile PLM for drawing and tolerance updates found during pilot builds.
R&D Engineering InternMay 2022 – August 2022Riverbend Diagnostics, St. Paul, MN
- Built a MATLAB script to process 1,200 sensor traces from a glucose test strip study, replacing a manual Excel process that took two days per batch.
- Assembled and tested 80 prototype cartridges for a point-of-care diagnostic, logging every result to the design history file.
- Drafted 3 bench test protocols that the senior engineer and quality team reviewed and approved for use.
- Presented intern project results to the R&D director, recommending a fixture change that was adopted for the next build.
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Tailor my resumeWhy This Resume Works
- Regulatory context is specific: a Class II steerable catheter and a 510(k) cleared in July 2026, which tells a device recruiter exactly what kind of program the candidate has worked on.
- Design controls, ISO 13485, ISO 14971 and V&V appear in both the skills and the bullets, matching the exact terms medical device postings screen for.
- Verification work is counted (22 protocols, 21 passing on first run, 4 validated test methods), so an early-career engineer shows output rather than just exposure.
- Bench and CAD skills are proven together: a quick-change Instron fixture designed in SolidWorks cut setup from 40 minutes to 10.
- The FE exam and EIT status are listed under certifications, a small signal that a three-year engineer is on the licensure path.
Common Resume Mistakes
- No device or regulatory context.
- Missing design controls or ISO keywords.
- Generic "designed devices" without outcome.
Keywords Recruiters Look For
- Biomedical
- Medical device
- FDA
- ISO 13485
- Design controls
- R&D
- Prototyping
- V&V
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