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Summary
This Software Development Consultant has broad engineer/project manager skills and leads teams to deliver the highest quality hardware and software and teams to complete electronic and display sensor based electro-mechanical projects on time. They have strengths spanning electronic hardware tests, electro-mechanical tests, software tests, software development, hardware/software quality, root cause analysis for hardware and software, Six Sigma, and statistical data analysis.
Highlights
- 30+ years of experience in hardware test, software development and software test
- 18+ years working with FMEACs in the Medical Device Industry
- Six Sigma from Motorola
- ISO13485, ISO62304, ISO14971, IEC 60601 and 21 CFR Part 11, 15, 90, 95,820 & MDD expertise
- Quality Improvement leader
- Software Test Process leader
- Software test planning expertise
- Skilled Presenter
- Skilled trainer and facilitator
- Project Management expertise
Relevant Accomplishments
- Led the multicultural R & D team on Solis Ambulatory Infusion pump restricted substance compliance upgrade project ($800,000) to complete by the deadline and under budget.
- Directed the multicultural R & D team on Legacy Ambulatory Infusion pump restricted substance compliance upgrade project ($1,200,000) to complete by the deadline and under budget.
- Directed the multicultural R & D team on time Medfusion Hospital Syringe Infusion restricted substance compliance upgrade project ($1,500,000) to complete by the deadline and under budget.
- Led an embedded software test team on a new Syringe Infusion pump for market release. Our diligent team tested the software using iterative SDLC. Result: After 2 years in the field no issues were reported.
- Created a new C++ test system application that cut device test time by 80%.
- Created a 90% complete test application using my Learner and Maximizer talent Strength Finder before completing formal training. Result: The application was released on time.
- Led/Tested offshore two-way handheld radio design team. Result: It outperformed the market leader Motorolas equivalent product.
- Performed all the required regulatory RF testing and wrote report for the FCC for Type Acceptance for the new handheld two-way radios. Result: FCC approved product to sell.
- Led a Six Sigma Problem team where we eliminated a product design issue that plagued manufacturing since the start of building the new low cost handheld two-radio
Request Expert / Similar Expert
Click “request expert” for a free initial screening call with this expert or a similar expert regarding your expert consulting needs
To apply for this job email your details to haleymmagnani@gmail.com
