PROGRESSIVE EXPERIENCE AND STRENGTHS:

●Medical Device ISO 13485, FDA CFR Title 21 Part 820, Tissue Regulations, Part 1270/1271, AATB Accreditations

●5 + Years risk assessment under ISO 14971:2019, ISO9001/AS9100, EU MDR 2017/745 and IVDR 2017/746 and 4+ years v ISO 10993-2018/2020 for biocompatibility, IEC 60601-1 (2020), ISO 22442-1: 2020 Animal Tissue (implants)

●Led B&L design of combo products. Redesign of the delivery system. (FDA, ISO, and EU approved)

●Led a team of engineers through New Product Development (NPD) under FDA 21 Part 820 for blood pressure monitors as well as technical review and approvals. Successfully owned Design Control process through Post Market Surveillance,

●Proficient in Optical comparators (GE Healthcare/Artemis), Gage R&R (GE Healthcare, Baxter, and Artemis, RTI), CNC tooling (GE), Clean Rooms (GE Healthcare Class 7, Baxter, Artemis Class 7 and RTI Class 5, digital calipers and micrometers, etc.

●IPC-610 certification/ 2010, IPC J-STD-001/ hands-on ability in SMT, PTH, materials in the manufacture of electronic circuit boards

●Certification of cleanrooms for Artemis Plastics for Certification and Validation for Medical Device review.

●Regulatory Compliance 510(k) team FDA 820, complaint trending, CAPA systems creation

●Professional Consulting Agency Owner specializing in medical devices and pharmaceuticals

●Project Management-design controls, GE Healthcare, Baxter, OB Medical

●Lean Manufacturing - GE Healthcare manufacturing facility in Juarez, MX

●Facilities Management-GE Healthcare in Juarez, MX

●Systems Engineering

●R&D-Medical Devices- Review of technical files, DMR, (Engineering, S/W, Clinical Reviews, audits of sources for approval, technical design reviews and creating a new documentation system using Oracle and Agile.

●Quality Management System responsibility

●Global Relationship Building

●Process Improvement and validations (IQ, OQ, PQ)

MAJOR ACHIEVEMENTS

Project Management:

Orchestrated and validated a centralized documentation system using Oracle/Agile to reduce GE Healthcare’s required procedures across Mexico, UK, and Florida sites.

Developed and maintained the Design History File and the Device Master Record for the BP monitors and other versions at GE Healthcare.

Directed manufacturing, quality, compliance, and regulatory projects to recover Baxter Healthcare from a failed 2004 FDA audit. Built a readiness team and established inter-departmental relationships to improve product design and development procedures, delivering presentations to corporate management and the FDA in the first and second quarters of 2007 with favorable results.

Restructured quality system procedures in compliance with ISO13485 and QMS. Very proficient skills with FDA requirements and strong abilities in utilizing EU requirements.

Built relationships with BSI and TUV to secure the CE mark for many product lines under ISO13485:2016 and EU MDR

2017/745 requirements. This includes Australian, Korean, and Japanese standards used to create an MDR Tech File.

CAREER HISTORY (Most recent 10 years)

GLG Consulting (Global Research), RA/QA May2022-Feb 2023

on call for tech problems concerning Med Devices/Life Sciences/EU/FDA/IVDR Regulations

Discussed the EU MDR requirements for the addition of a cleanroom class7

Customer wanted to understand the regulatory technicalities for CE marking on their international products.

Customer wanted a cleaning plan for aluminum for medical devices. He and I wrote the plan together.

Avanos Healthcare Contract Regulatory Consultant Feb2022-Apr 2022

Performed Risk Analysis (Human Factor) ISO 14971:2019 for a short project another consultant had been working on.

I redeveloped the risk matrix since the only one done was years ago and not to ISO 14971:2019

Reviewed Biocompatibility and Clinical Reports for submission to notified body BSI

I updated the Bio Compatibility Report to conform with the new regulation ISO 10993:2020.

Philips Healthcare Contract Mar2021-Oct 2021

Regulatory Consultant

Remediation of Tech Files for presentation to the EU MDR.

Class I and Class II remediations

Tasked with the review of some legacy product family complaints for the sleep apnea product to see the extent of the number of complaint and Post Market Surveillance inquiries.

PMS and complaints were numerous, and this triggered a recall and replacement of the product

Milliken Healthcare Contract (EU MDR Regulatory specialist) Jun 2021-Aug 2021

PM for Milliken’s EU MDR Project. Some were legacy and one was an NPI project.

Establish a gap analysis for their legacy products

Developed and maintained a requirement matrix for class I and class IIa for their legacy products which included Risk Assessments, clinical reviews and review of Biocompatibility Reports.

Integra Life Sciences Contract Sept 2020-Feb 2021

Regulatory Consultant

Worked with Integra Life Sciences as a Consultant to review Class I, Class IIa, Class IIb, and Class III devices and to remediate their Risk Management Compliance to the new ISO14971:2019 and present updated technical files to the new European Union Medical Device Regulation, 2017/745.

Worked with regenerative tissue specifications for Bovine tissue under EU722/2012, European Union Commission Regulations for animal tissue requirements for human use.

ConvaTec, Ltd Nov 2019-Jun 2020

Senior Associate Consultant

Consulted with a client, ConvaTec Ltd, to remediate and present technical files to the new European Union Medical Device Regulation, 2017/745 for Class I, Class II, Class III, medical devices.

Wrote the Biocompatibility Evaluation Plans (BEP) for Class I and Class II products and revised the Biocompatibility Evaluation Reports (BER) to the updated requirements of ISO10993-1 (2018).

Created a traceability matrix (Class I, II) and the Risk Assessment matrix to comply to the ISO14971-2019.

Generated a GSPR (General safety Performance Requirements) for all technical files for Class I and II.

Successfully completed Class I and a partial completion of Class II Technical Files remediation for presentation to the EU

RTI Surgical, Inc. Aug 2018 - May 2019

Sr. RA/QA Engineer

Worked with new processes (developing new tooling for tissue processing) for human tissue for implantation in the mesh process. This included combo products for a prefilled syringe for dental paste for a new NPD project.

Created a Risk Matrix using ISO 14971 for processed tissue.

Added my expertise to the aseptic “sterilization” process using the BioCleanse and Tutoplast processes. These processes added a measure of protection to provide a natural biologic scaffold in orthopedics.

Teamed with sterilization engineers to review and rewrite procedures for tissue splitting (new tooling) and the Cancelle SP sterilization process to demineralize bone for use as bone fillers for trauma, joint reconstruction and dental surgeries.

Watershed Ideas Foundry/Jabil Corp. Jul 2017 - Aug 2018

Sr. Principal Quality Engineer Consultant

Worked with Alaris Biotechnologies to update the QMS for the FDA and AATB tissue banking requirements. Later recruited to consult on technical manuals for circuit boards for a Jabil contract project for Medtronic.

Contract completed successfully.

Artemis Plastics - Ocala, Florida Feb 2016 – Feb 2017

Mgr. Quality Systems, Quality Control, Documentation Audits

Company designs Plastics for commercial (70% of business) and some medical device (30% of business).

NPI Projects included revamping the calibration system to make it more efficient per QMS requirements. Introduced a CAPA system to review concerns from the customer (Orthofix) during their Post Market Surveillance.

Developed pFMEAs for molded syringes used in the medical devices.

Prepared Artemis for their first FDA audit. Audit was successful.

OB Medical Company - Newberry, Florida Jan 2015 - Aug 2015

Director RA/QA

Company designed and manufactured medical monitors and was a startup company designing other medical device equipment. Having created the QMS, per ISO 13485/FDA CFR820 for these devices and validating the documentation system and using Six Sigma to solve manufacturing problems.

Company closed in 2016 due to lack of funds.

Sibex Electronics - Crystal River, Florida 2013 - 2014

Manager Quality Assurance

Joined the company to add expertise to the electronics industry (PCB manufacturer) while preparing them for certification with the FDA CFR 21 820, ISO 13485 and ISO 9001. This included 3 locations and two additional inspectors at each facility.

Took complete ownership of the weekly MRB and reviewed and took completion of complaints from customers.

Initiated vendor audits and subsequent statistics for on-time and acceptance criteria for all vendors.

Directed a team of 12 inspectors throughout 3 facilities for PTH, SMT, and Mechanical certifications using IPC-610 and J-STD-001.

Contract Engineering Services: 2011 - 2018

Jabil Consultant (May 2018-Sept 2018) - worked with Jabil building a monitor (engineering model) for Medtronic. Remediation reviews for Medtronic. Validated a documentation system from Agile to SAP prior the contract to build a renal monitor for Medtronic.

Zimmer (Ind. Contractor in 2014, 2015, 2016) Worked with engineers and quality to review complaints, review design controls and suggest changes (under document control) to mitigate complaints in a timely manner.

●RCA Associates -Tampa, FL Aug 2012- Dec 2012

oSr. Quality Engineer/Operations Engineer

●Sparton Electronics-Brooksville, Florida 2012

oAdvanced Manufacturing Engineer

●CAE Inc. -Tampa, Florida 2011-2012

oSr. Quality Software Engineer

NOTEABLE EARLIER WORK:

Contract Engineering Services:

●Smith & Nephew Florida USA 2007-2009

oprepared the wound products and negative pressure instrumentation for transfer to China

Contract Senior Quality Engineer-Smith & Nephew (2008-2009) St. Pete, Florida

Ind. Contract Senior Quality Engineer/Quality Analyst-Jabil Circuit (2007)-Tampa, Florida.

Baxter International - Largo, Florida/Round Lake, IL 2005 - 2007

Sr. Principal Quality Engineer

Joined Baxter to remediate a failed FDA audit.

Developed, owned and controlled both DHF and the DMR through documented design changes and was sole Quality approver when each phase was completed.

Validated a CAPA system using Trackwise.

FDA did a follow-up audit in R&D and Manufacturing. Following the audit, the “Cease and Desist” letter was removed and the 483 was successfully closed.

GE Healthcare –Tampa, Florida 1999 - 2005

Manager of Engineering Services

Developed the design of the DHF and the DMR during the design control stages of the BP Monitors and other versions.

Conducted technical reviews for each phase of the design. All changes to the development were done under design control per FDA 21 CFR 820.30.

Assisted Regulatory Affairs in presenting the 510(k) when the NPI design was completed and the creation of the DHF was in its final stages. FDA technical review took 6 months and several changes and explanation were required. Presented the changes that resulted in the approval of the 510(k).

Bausch & Lomb-Clearwater 1992 – 1999

Sr. Quality Engineer/Manufacturing Engineer

Led a team from B&L and Sanofi through a redesign of the delivery system of a drug, Ocucoat (combo product) used in Ophthalmic surgeries.

Reduced the surface area of the plunger to glass vial ratio. Also reduced the amount of silicone needed for delivering the drug as needed by the MD. Ocucoat is very viscous and difficult to expel.

Optimized the aseptic fill finish process to reduce filling accidents on the production line. Ocucoat tended to leak through the bottom of the vial causing constant line clearances and timing problems. The plunger was placed first and the drug was placed second from the bottom. A cap was placed on the end of the syringe for closure and the inspected for any leaks.

To make the manufacturing process more cost friendly, the fill finish process site was moved from Sanofi in Kansas to B&L in Tampa, Florida

EDUCATION

BS Business Engineering; Michigan Technological University

BS Metallurgy; Michigan Technological University

AS Computer sciences; Gannon University

Tooling Engineering; Penn State-Behrend Campus

CERTIFICATIONS

Six Sigma Green Belt, GE

Lean Certification, GE

Certified Quality Engineer (CQE), American Society for Quality (ASQ)

SOFTWARE PROFICIENCIES

Microsoft Office (Word, Excel, Powerpoint, Outlook)

Other Microsoft Applications: MS Project, Sharepoint, Teams

Other (Non-Microsoft) Applications: Trackwise, Agile, SAP, Oracle, Windchill, Minitab, SmartSolve, Egnyte

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