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Design Assurance, Software Engineer, Medical Device

Location:
Minneapolis, Minnesota, United States
Salary:
60000
Posted:
February 22, 2019

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Resume:

Software Engineer

Profile

Accomplished, goal-oriented, and result-driven professional entering the workforce.

Proven leadership ability.

Proven ability to follow directions to project completion.

Ability to handle diverse projects and meticulous details.

Skills & Abilities

·C programming

·Java programming

·C++ programming

·Concurrent Programming

·Regulatory document control

·Microsoft Office

Interests

·Artemis Club

·Broomball

·Drawing

·Reading

·Rock Collecting

·Material Arts

Experience

WORK EXPERIENCE

Quality & Regulatory

Medibio – Savage, MN

June 2018 - December 2018

Improved the state of the company’s quality management system. Worked with medical device standards and regulatory documentation.

Created documentation to verify off the shelf software.

Participated in an audit against ISO 13485:2012 medical device quality management system standard.

Took on responsibility for creating and executing document change orders.

Updated quality and regulatory documentation.

Familiarity with FDA Article 21 CFR 820.

Began work to train employees on new documentation.

INTERNSHIPS

Smiths Medical – Minneapolis, MN

2015 & 2016

Successfully completed two summer internships at Smiths Medical. Working in the areas of requirements and verifications has developed real world experience and broadened abilities.

2016

Wrote customer requirements, use cases, prototypes, and mockups for a mobile service app.

Used IBM Rational DOORS, Agile PLM, and JustInMind.

Presented a summary of work to company managers.

2015

Performed formal verification and validation on the Medfusion 4000 pump.

Performed ad-hoc testing and wrote test procedures.

Used IBM Rational DOORS, Mantis Bug Tracker, and PDF Annotator.

Presented a summary of work to company managers.

DEGREE PROGRAM

Michigan Technological University –Houghton, MI

May 2018

Bachelor’s Degree Computer Science – Minors in Math & Writing

Obtained a degree in Computer Science at one of the most prestigious engineering colleges in the United States.

Worked independently and collaboratively on multiple languages as well as functional knowledge across a wide swath of current technologies.

References available upon request



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