Amanda Spilkin
Saint-Lambert,QC
Summary
Throughout the last 10 years, I have had the opportunity to work in several roles in medical device development and aerospace industries. My choice of projects and career experiences have shaped a well-rounded skill set in which I can effectively communicate technical information others across multiple disciplines. I have a strong passion for aviation and have first-hand experience in flight as I am currently pursuing my private pilot license.
Overview
10
10
years of professional experience
1
1
Certification
Work History
System Designer, Systems Engineering
Zimmer Biomet
03.2021 - Current
- Provided technical leadership to team members during system design.
- Applied medical device lifecycle management/design control process in development and release of OptiVu ROSA Mixed Reality (MxR) platform upon Microsoft’s Hololens2. The goal of this product lies in pioneering MxR technology for surgeons’ use in the operating room and improving quality of surgeries.
- Performed technical verification, validation, risk management implementation and analysis of the product and its integration into larger surgical workflows.
- Worked alongside design quality engineering team and regulatory affairs teams in technical documentation and submission for 510K approvals.
- Developed technology products in compliance with ISO 13485 – Quality Management Systems (Medical Devices) and FDA 21 CFR Part 820, ISO 14971 (Risk Management, Medical Devices), and IED 62366-1 (Application of Usability Engineering to Medical Devices).
Founder, Lead
Space Health Division, Concordia University
02.2019 - 09.2022
- Oversaw tasks and deliverables across five subdivisions: Payload and Automation, Data Analysis, Experimental Biotechnology, Bio/Genetics and Business Development.
- Organized and delivered technical reviews, Preliminary Design Review (PDR) and Critical Design Review (CDR), writing scientific proposals and grant applications.
- Space Health Division projects: Generated (1) design, manufacturing, integration and testing of payload system containing biological samples, and, (2) design, manufacturing, verification and validation of Cardiopulmonary Resuscitation Assistance Device (CPRad) for improving performance of successful CPR on Earth and in Microgravity.
Research Graduate Student
Concordia University
01.2019 - 01.2020
- Consulted and performed data acquisition for Neptec (MDA) in the continuous development of fNIRS portable brain imaging sensors for pilots (Contract with the Canadian Space Agency as of April 2019: Development of Health Technologies for Deep Space Missions).
Expert / Technical Expert
Apple
08.2013 - 07.2017
- Expert position consisted of working alongside management to oversee sales performance of employees, curated workflow optimization, business strategies, producing progress reports, coaching employees in hardware/software. Technical expert position involved diagnosing tech issues devices and perform required hardware repairs.
- Career Experience: “Lead and Learn”. This program is a six-month experience in which I trained 50+ new employees.
Education
Ph.D. - Mechanical Engineering
Concordia University
Montreal, QC12.2026
Master of Science - Physics
Concordia University
Montreal, QC08.2021
Bachelor of Science - Physics
Concordia University
Montreal, QC12.2017
Skills
- Device Lifecycle Management
- Design Control
- Verification & Validation Process
- Technical Documentation
- Servicing Procedures
- Agile Work Environment
- Flight Dynamics
- MATLAB / Simulink
- Python
- Effective Communication Skills
- Teamwork
- Critical thinking
Certification
- Project Management Professional (PMP) Certification (In Progress)
- Field Service Engineering (FSE) Certification, Zimmer Biomet
Languages
- English (Native Language)
- French (Native Language)
- Polish (Full Professional Proficiency)
- Ukrainian (Professional Working Proficiency)
- Russian (Professional Working Proficiency)
- Spanish (Professional Working Proficiency)
Timeline
System Designer, Systems Engineering
Zimmer Biomet
03.2021 - Current
Founder, Lead
Space Health Division, Concordia University
02.2019 - 09.2022
Research Graduate Student
Concordia University
01.2019 - 01.2020
Expert / Technical Expert
Apple
08.2013 - 07.2017
Ph.D. - Mechanical Engineering
Concordia University
Master of Science - Physics
Concordia University
Bachelor of Science - Physics
Concordia University
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