Andrew Malkiewicz Email & Phone Number

MA, 01824, US

- Interview current users, subject-matter experts, training, and sales staff to anticipate product use errors.- Design and run usability experiments with recruited users for wearable heart sensor and Zoll LifeVest garments. - Interpret qualitative and quantitative usability research data with preferential feedback collected from debrief surveys. - Manage.

Led overall effort with Regulatory and Quality groups to establish a Human Factors Engineering process. Rewrote work instructions and SOPs from the ground up, created templates for all deliverables including Usability Engineering: Plan, Task Analysis, Test Protocols, Reports. Managed Human Factors engineering file of requirements, analyses, protocols, test.

Leverkusen, North Rhine-Westphalia, DE

Exposure and education in human factors engineering. Led simulated clinical testing of 50+ customers, key opinion leaders, and user groups for contrast injector systems. Generated medical device improvements by leveraging customer feedback to identify areas for improvement. Revalidated improvement to demonstrate increased safety and customer satisfaction..

Pittsburgh, PA, US

• Thesis project: U.S. PATENT PUB.# - 20140228918 A1. Designed and synthesized a prototype cushion containing temperature control features by collaborating with a multidisciplinary team of scientists, engineers, PTs.
• Developed, modified, and evaluated testing guidelines, IRBs, and SOPs concerning data acquisition for pilot clinical studies on the effect of temperature and pressure on patients undergoing transplant, spinal fusion.
• Presented reviews of current literature and scientific conclusions, and recommendations to industry partners and academic advisers. Communicated this information through roles as an research investigator.
• Participated in the development of national and international standards for cushion temperature characteristics: ANSI/RESNA, ISO

Pittsburgh, PA, US

• Assisted with documenting ACL, PCL, and meniscus repair procedures in operating rooms, cath/wet labs, and benchtop laboratory settings
• Facilitated communication between researchers, lead clinician, medical students, and industrial partners.
• Conducted experiments on knee joint contact coupled with synthesized meniscus tears. Prepared and dissected cadaver knee specimens, acquired and computationally / statistically analyzed data.
• Prepared manuscripts, grant applications, and presentations for scientific meetings: AOSSM, AAOS, ORS, AANA, ISAKOS
• Designed and manufactured testing fixtures, mentored students, procured equipment and experimental specimens.

• Recorded, edited, and published bi-weekly podcast featuring internationally recognized figures in regenerative medicinewww.regenerativemedicinetoday.com

Bloomington, Indiana, US

• Attained practical, professional experience in the field of medical device engineering (pacemaker lead extraction technologies)
• Designed prototype of fixture cuff for Cook Doppler Flow Probe
• Educated in quality systems and design controls (21 CFR 820.30, ISO 9000), internal auditing, document control, patents, PMA and 510K, as well as laws and regulations affecting medical devices

Pittsburgh, PA, US

• Designed and coded Matlab software capable of analyzing ultrasound images of the median nerve
• Utilized this software in a randomized study on the effect of wheelchair use on median nerve health
• Consented, prepared, and acquired ultrasound images of median nerve at various levels of the wrist for study participants

Master Of Science, Biomedical Engineering

Bachelors Of Science, Biomedical Engineering