Mara Lindqvist

Senior Biomedical Engineer

mara.lindqvist@email.com · +1 555 0147 · Minneapolis, MN · linkedin.com/in/maralindqvist-bme

Education

M.S. Biomedical Engineering2013 - 2015
University of Minnesota, Minneapolis, MN
Thesis: Fatigue Characterization of Nitinol Cardiovascular Implants Under Physiological Loading Conditions
B.S. Mechanical Engineering2009 - 2013
Iowa State University, Ames, IA
Minor in Biology; Dean's List 6 semesters

Skills

FDA 510(k) & PMA Submission Support · ISO 13485 / 21 CFR Part 820 QMS · Verification & Validation (V&V) Protocol Development · Finite Element Analysis (FEA) — ANSYS · ISO 10993 Biocompatibility Assessment · SolidWorks (CSWA Certified) · Design History File (DHF) & Risk Management per ISO 14971 · Accelerated Life & Fatigue Testing · MATLAB & Python for Data Analysis

Links

LinkedIn: linkedin.com/in/maralindqvist-bme · Portfolio: maralindqvist.com/bme-portfolio · PE License: Minnesota Professional Engineer License (verifiable via state board)

Profile

Senior Biomedical Engineer with 9 years of experience in Class II/III medical device development, verification and validation, and FDA 510(k) submission support. Specializes in implantable cardiovascular devices and biomechanical testing protocols at the intersection of mechanical design and regulatory compliance. Led V&V programs that reduced submission cycle time by 22% and contributed to two cleared devices now generating combined annual revenue exceeding $38M.

Work Experience

Senior Biomedical EngineerMar 2020 - Present
Cardivex Medical Systems, Minneapolis, MN
  • Designed and executed V&V test protocols for a transcatheter heart valve system under ISO 5840, cutting pre-submission deficiencies by 34% across two FDA 510(k) filings
  • Led a cross-functional team of 6 engineers to redesign a nitinol stent delivery mechanism, improving deployment consistency by 18% and reducing adverse-event rate in bench testing from 4.1% to 0.6%
  • Built and maintained DHF documentation in compliance with 21 CFR Part 820 and ISO 13485, enabling a zero-finding internal audit for three consecutive years
Biomedical Engineer IIJun 2017 - Feb 2020
Neurotek Devices, Eden Prairie, MN
  • Developed finite element analysis (FEA) models in ANSYS for spinal cord stimulation lead electrodes, reducing physical prototype iterations by 40% and saving approximately $210K in annual material costs
  • Authored biocompatibility risk assessments per ISO 10993 for three product lines, all accepted by FDA without additional information requests on first submission
  • Collaborated with clinical affairs to analyze 1,200+ post-market surveillance records, identifying a fatigue failure mode that informed a design change preventing an estimated 90 field complaints annually
Biomedical Engineer IAug 2015 - May 2017
Luminos Diagnostics, Rochester, MN
  • Supported bench and accelerated life testing for an optical glucose monitoring prototype, generating datasets that validated a 5,000-cycle fatigue life requirement ahead of schedule by 6 weeks
  • Wrote and executed IQ/OQ/PQ protocols for two new test fixtures, achieving measurement system analysis (MSA) Gage R&R results below 10% for both systems
  • Coordinated with contract manufacturers to resolve 14 open CAPAs within a single quarter, reducing backlog by 73% and restoring on-time delivery to 96%