Michael V. Phenner
Dover
Summary
Accomplished Senior Quality Engineer with more than 15 years of experience in developing and validating medical devices in secure facilities. Possessing exceptional organizational, communication, and technical critical thinking skills, I am recognized as a seasoned and dedicated team player. Known for efficiently managing multiple tasks, I consistently elevate levels of competence and integrity.
Overview
27
27
years of professional experience
Work History
Sr. Quality Engineer
Neutron Therapeutics
11.2019 - 09.2024
- Company Overview: Developer of Boron Neutron Capture Therapy (BNCT) neutron beam-based cancer treatment systems
- Managed NCR, CAPA, Calibration, Inspection (via GD&T), Doc
- Control, and suppliers via SolidWorks PDM
- Maintained suppliers and their QMS per FDA QSR and ISO 13485/14971/17025/9001 requirements
- Authored SOPs, Work Instructions, Test Procedures, Verification/Validation documents and risk assessments
- Integral team member in building, installing, and validating 3 oversea $20M+ BNCT cancer treatment systems
- Developer of Boron Neutron Capture Therapy (BNCT) neutron beam-based cancer treatment systems
Sr. Quality Engineer
ProTom International
04.2011 - 11.2019
- Company Overview: Developer of synchrotron-accelerated proton beam-based cancer treatment systems
- Authored SOP, WI, Risk Assessment, assembly, test, labeling, setup, installation, PM & servicing processes
- Internal & Supplier Audits suppliers and their QMS processes per FDA 21 CFR 820 and ISO 13485/9001
- Managed NCR, CAPA, Suppliers, Inspection and Document Control (via PTC Integrity & Oracle Arena PLMs)
- Integral team member in building & installing 2 U.S
- $25M+ proton beam cancer treatment systems
- Developer of synchrotron-accelerated proton beam-based cancer treatment systems
Quality Engineer (contract)
Covaris, Inc.
11.2009 - 03.2011
- Company Overview: Developer of high power, focused-ultrasonic systems for CSI & other molecular-level diagnostic purposes
- Created, qualified, and executed bench and system-level testing for new & existing ultrasonic products
- Performed investigatory testing, inspections, and vendor qualifications as QA MRB committee member
- DOE, Risk assessment, troubleshooting, & root cause analysis on electronic systems, PCBs, & Components
- Developer of high power, focused-ultrasonic systems for CSI & other molecular-level diagnostic purposes
Quality Engineer
ESA Biosciences
04.2008 - 07.2009
- Company Overview: Developer of High-Performance Liquid Chromatography [HPLC] and blood-lead detection systems
- Assisted in new product design, risk assessments, & design verification/validation testing for R&D/MFG
- Managed ECOs, calibration, training, complaints, NCR & CAPA systems via Oracle Enterprise ERP
- Mitigated supplier defects 50% via supplier corrective actions as MRB committee member
- Developer of High-Performance Liquid Chromatography [HPLC] and blood-lead detection systems
Quality Engineer/Test Lab Manager
OmniSonics Medical
12.2005 - 11.2007
- Company Overview: Developer of ultrasonic catheter-based technology used in treating Peripheral Thrombosis
- Performed design verification, validation, risk analysis, and EMC testing for Quality, R&D/ MFG
- Managed ME/EE laboratory personnel & performed medical equipment qualifications (IQ/OQ/PQ)
- Reduced open issues by 75% Manager of the Corrective And Preventative Action (CAPA) committee
- Developer of ultrasonic catheter-based technology used in treating Peripheral Thrombosis
Quality Engineer (Contract)
RSA (Cyber) Security
10.2004 - 09.2005
- Company Overview: Developer of identity, authentication, and access solutions for ultra-secure organizations
- Performed hardware and software-based security identity token testing, verifications, and validations
- Created, qualified, and validated testing fixtures and equipment in controlled laboratory environments
- Pre-screened & agency-lab evaluated security tokens for EMC, Safety, Shock, Drop, HALT/HASS testing
- Developer of identity, authentication, and access solutions for ultra-secure organizations
R&D Lab Manager/Engineer II
Abbott Diabetes Care
03.1998 - 10.2004
- Company Overview: Developer of blood-glucose test devices and systems for Diabetics and hospitals
- Created medical device test fixtures, procedures and V&Vs for R&D, QA, & MFG per ISO 13485/17025
- Pre-screened ASIC integrated medical device metrology products for EN 60601-1, FCC, FDA, and UL
- Hired & supervised electrical, mechanical, and environmental R&D laboratory engineering personnel
- Developer of blood-glucose test devices and systems for Diabetics and hospitals
Education
Quality System Requirements and Industry Practice formal training completion certificate -
AAMI
09.2017
Bachelor's degree - computer science
Franklin Pierce College
Rindge, NH01.2001
Skills
- Create ECOs
- FMEAs
- IQ/OQ/PQ
- Testing & risk management documentation per FDA QSR
- ISO 9001/13485
- Win(all)
- C
- HTML
- Linux
- SolidWorks PDM
- PTC Integrity
- Oracle Arena
- MS Office(all)
Timeline
Sr. Quality Engineer
Neutron Therapeutics
11.2019 - 09.2024
Sr. Quality Engineer
ProTom International
04.2011 - 11.2019
Quality Engineer (contract)
Covaris, Inc.
11.2009 - 03.2011
Quality Engineer
ESA Biosciences
04.2008 - 07.2009
Quality Engineer/Test Lab Manager
OmniSonics Medical
12.2005 - 11.2007
Quality Engineer (Contract)
RSA (Cyber) Security
10.2004 - 09.2005
R&D Lab Manager/Engineer II
Abbott Diabetes Care
03.1998 - 10.2004
Bachelor's degree - computer science
Franklin Pierce College
Quality System Requirements and Industry Practice formal training completion certificate -
AAMI
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