Anthony “Tony” Simiele
Experienced medical device professional with an accomplished 25+ year career of designing, launching, producing and supporting medical devices globally. Have taken several Class II systems from concept through market end of life for Fortune 500 medical device companies. Background in dialysis and apheresis systems, extracorporeal / patient access devices, RF ablation pain management systems and kits, surgical thermoregulatory management systems and vascular harvesting.
- Design Control/Product Development
- Design History Files/Design Changes
- Design Verification/Design Validation
- Process Controls/Process Validations
- Corrective and Preventative Action
- Problem Solving/ Fault Cause Analysis
- Failure Investigations/Complaints
- Change Controls/Change Initiatives
- Post Market Initiatives/Medical Device Reporting
- Risk Management/FMEA/Hazard Analysis
- 21 CFR Parts 11/803/806/820
- ISO 13485/ISO 14971
- Portfolio/Project Management
- Problem Solving Tools/Data Analysis
- Managed from concept through release new ISO 594-2 compliant access / administration kits for RF Ablation, managing all aspects of design controls.
- Designed, launched and supported innovative medical instruments and disposable devices from concept through market end of life in the dialysis, RF ablation sectors and thermoregulatory markets.
- Addressed FDA 483 and Warning Letter Observations; performed remediation activities for clients while under Consent Decree.
- Led global cross functional teams in definition, prioritization, management and implementation of design changes and process improvements aligned with business objectives.
- Concurrently managed and delivered programs for both internally and externally developed medical devices in the global dialysis, RF pain management and thermoregulatory markets.
- Staffed and managed a team of 18 engineers that developed and performed over 30 subsystem design validations resulting in test reports that were key in obtaining a first pass FDA 510K approval of new Hemodialysis instrumentation system.
- Managed over 20 CAPA and FCA compliance programs in the dialysis and thermoregulatory sectors from initial assessment through closure, presented programs and provided recommendations to senior management.
- Staffed and led engineering team of 7 responsible for implementing design and process improvements that increased reliability, reduced defects and decreased product costs which resulted in increased sales in the dialysis market.
- Led injection molded parts improvement program; revised tooling and supplier processes resulting in significantly improved reliability while decreasing costs.
- Monitored system performance and customer satisfaction for multiple devices in global dialysis and thermoregulatory market. Reviewed complaints and trends, performed risk management reviews and managed appropriate remediation. Wrote technical summaries and MDR technical content.
- Served as divisional Hemodialysis technical expert adept at analyzing complex system failures or product complaints to root cause, proficient at disseminating results to non-technical staff or customers.
- Supported internal, external and FDA compliance audits.
- Met with hundreds of dialysis customers globally as technical expert; obtained direct input from customers; created and presented customized technical sales presentations; formally presented products at international trade shows.
- Planned and managed capital budget in support of process and design improvements.
- Medical Device Solutions, Consultant – 2014 to 2015
- Kimberly-Clark Corporation, Health Care R&D, Technical Leader – 2010 to 2013
- Baxter Healthcare, Renal Division, Engineering Specialist (Senior Project Manager) – 2005 to 2009
- Baxter Healthcare, Renal Division, Engineering Specialist (Project Manager) – 2001 to 2005
- Baxter Healthcare, Renal Division, Senior Principal Engineer (Tech. Product Manager) – 1997 to 2001
- Baxter Healthcare, Renal Division, Principal Engineer (Technical Product Manager) – 1996 to 1997
- Baxter Healthcare, Renal Division, Senior Engineer – 1991 to 1996
- Baxter Healthcare, Renal Division, Senior Product Design Engineer -1989 to 1991
- Baxter Healthcare, Renal Division, Product Engineer – 1987 to 1989
- Baxter Healthcare, Renal Division, Junior Product Engineer – 1986 to 1987
- Bachelor of Science, Electrical Engineering Technology, Northeastern University, Boston, MA – 6/1985
- Requirements Management
- Technical Writing
- Project Management
- ISO 13485
- ISO 14971
- PMP Exam Prep Course
- Lead Investigator
- TrackWise 7 & 8
- Problem Solving / Critical Thinking
- Injection Molded Medical Devices
- IEC 6060
- Project Management Institute – 10/2013 to Present
PUBLICATIONS AND PRESENTATIONS
- US Patent 20090198170 “Multi-pass dialysis” – August 6, 2009
- US Patent 20090008306 “Extracorporeal dialysis ready peritoneal dialysis machine” – January 8, 2009