WILLIAM A. DeVROOM ***** S. Eureka Dune Drive, South Jordan, UT 84009

909-***-****, email: ad112p@r.postjobfree.com

PROFILE

BSME (University of Pennsylvania), MBA (Claremont Graduate School); certifications Lean Six Sigma Black Belt and ISO 9001/ISO 13485 Lead Auditor; 8 Patents; pragmatic quality practice and regulatory compliance leadership.

Over thirty years successful multifunctional domestic and international experience in product development for industrial, consumer and medical products achieving over $100 Million increase in annual sales and cost reductions.

Professional individual contributor and managerial roles: Design Engineer (GE), Manager Product Development (J&J), Engineering Manager (Alcon Labs), Associate Director Business Development (Genzyme Pharmaceuticals), Program Director & Director Quality Leadership (Baxter Healthcare), plant Quality Manager & Director of Quality (Orchid Orthopedic Solutions, ServTech); domestic and international consultant for regulatory compliance, audits and remediation (ISO9001, ISO13485, ISO60601, ISO14971, MDSAP, EU MDR).

Regulatory experience with submissions for medical devices (PMA, IDE, 510k) and pharmaceuticals (NDA, IND) while working for Fidus, ResMed, Baxter Healthcare and Alcon Labs to US FDA, Canada, Europe, Australia and Japan. Corporate Management Representative to FDA, notified bodies, customers and related audits.

Teaching experience in Program Management, Risk Management, Quality, Managing in a Global Economy, Change Management, Marketing and Negotiations for University of La Verne, DeVry University and California State.

Pragmatic Emphasis on Quality and Profitability

Market research, product and process specification, market launch, sales promotion and contract negotiations tripling sales and profitability. Disciplined methods for controlled production and key metrics. Open to Relocation and Travel.

Vision & Motivation

Self-motivated achiever with both analytical and innovative “big picture” perspective in coordinating multiple disciplines. Eight patents. Various corporate recognition awards for bringing over thirty products from concept through commercialization. Mature with strong work ethic and integrity. Successful program management, direction and mentoring of up to forty employees

Medical Device & Pharmaceutical Product

Device and combination drug products. cGMP work with actives and excipients (Baxter, Cygnus, Alcon, Genzyme) including peptides, amino acid derivatives, lipids, drug delivery technologies, aseptic solutions and sterilization techniques. Regulatory submissions and reviewer interface: 510k, PMA, IND, NDA

Individual Contributor and Managerial Skills

Design and development with Design Control ISO14971 Risk Management, FMEA, ISO 60601-1 compliance. Verification & Validation, IQ/OQ/PQ, Statistical Process Control, CAPA and Root Cause analysis, monitoring of MAUDE/TPLC data. Contributor to QA, QC and Regulatory activities. Managed internal and FDA audits and responses.

Accomplishments include:

Designed, developed, implemented and achieved certification of full corporate Quality Management System to ISO 9001 and ISO 13485 standards. Developed Supplier Quality Assurance methods, metrics and audit standards. Implemented eQMS system (MasterControl). Established production documentation; cleanroom installation, monitoring and control; inspection and metrology. Compliance testing (UL, TÜV, CSA).

Directed $4.2 million National Institutes of Health contract for first fully implantable artificial heart LVAD system. Concurrently launched TQM and Product Development processes (PDP/ISO9000), directed CIP teams based on Kaizen/Deming principles, and provided documentation for PMA, 510(k) regulatory submissions.

Won “Sunrise Corporate Speed Award” for design and project management in bringing DME controller product from concept to market in only 6 months’ time and resulting in 45% sales growth in decubitus ulcer market.

First to validate radiation as an alternate sterilization method to EtO at Baxter saving $10 Million in annual costs. Ran GMP production start-ups in U.S. and Europe, including MTBE drug aseptic sterile fill process.

Brought “combination” (device-drug) product from early prototype through scale up production launch in Europe with equipment design, pFMEA, IQ/OQ/PQ, testing methods validations and documentation. Streamlined manufacturing processes with improved quality methods increasing through put by 27%.

WILLIAM A. DeVROOM 909-***-**** / ad112p@r.postjobfree.com / page two

EXPERIENCE HIGHLIGHTS

Interim Consulting: ICU Medical (Supplier Audits): Nutraceutical Audits and consulting; Belluscura (CAPA, Internal Audits, Training. SOP and QMS using Greenlight Guru for ISO13485 certification); Flexan (Validation Program Lead for Manufacturing Transfer of high tech brain catheters). April 2021 - Present

JOHNSON & JOHNSON, Ethicon EndoSurgery (EES), Megadyne, Draper, UT

JJRC Site Regulatory Compliance Lead / Lead Auditor (contract) March 2020 to March 2021

Planned and conducted Internal Audits in compliance to MDSAP/ISO13485 and EU MDR regulations. Supported response to External Audits by Notified Bodies and Regulatory Authorities. (One year contract)

Research, Planning, Development Consulting Services December 2019 to February 2020

Internal audits, consulting and teach training for ISO9001, ISO13485, MDSAP, EU MDR, Root Cause Analysis, CAPA and ISO14971/Risk Management with AXEON and companies in Utah and California,

STRYKER, Salt Lake City, UT EU MDR/Supplier Quality Contractor October 2018 to October 2019

EU MDR project for North American Operations (including Neurovascular and Orthopedics groups) with focus on product compliance changes and supplier quality engineering management to meet new regulations replacing prior MDD. Provided Class IIa/IIb/III Technical File and 510(k) support for Product Part Approval Process (PPAP) and Chemical & Material Analysis (CMA). (One year contract)

PROVIDIEN PMM, Sylmar, CA Senior Quality Manager June 2017 to June 2018

Direct QA, QC and Documentation activities for OEM medical device machining division of OEM medical device firm. Report to corporate Senior VP of Quality and Regulatory Affairs. Serve as Management Representative for audits and customer communications. Provide leadership for QMS and production process improvements and ongoing quality support for the division. (Assignment end with completion of QMS transition and re-registration to new ISO 13485:2016 requirements).

SERVTECH Plastics, Monrovia, CA Director of Quality June 2015 to April 2017

Report to the company President and provide overall quality leadership for a growing international custom injection molded plastics product manufacturer with operations in Monrovia, California and Guangzhou, China. Quality Management Representative for internal and external relations to customers and regulatory authorities and travel to conduct supplier audits and customer business support.

Designed, developed and achieved certification of full corporate Quality Management System (QMS) in compliance with GMP, ISO 9001 and ISO 13485 standards. Implemented eQMS MasterControl. Ensure quality systems deployed. Determine quality metrics and direct audits. Develop resources for inspection and metrology and utilized statistical methods, quality tools and reports to continuously improve process capability. Established methods for dealing with non-conforming material and Material Review Board disposition. Analyzed and improved operations in Guangzhou, China with V&V services, implementation of protocols and reports to new standards for operations methods, cost and quality objectives.

MERIT Medical, Salt Lake City, UT Senior Quality Engineer, R&D June 2014 to February 2015

Design Compliance, Risk Analysis, FMEA, HSA and ISO14971, DOE and test protocols, Verification & Validation, equipment IQ/OQ/PQ, support for Design History File and FDA submissions, Field Complaint and MAUDE/TPLC monitoring and responses, production quality assurance, Developed SPC, inspection methods. Supported Class I/II/III Technical File and 510(k) submissions. (Interim position until corporate organization restructuring with layoff of 25+).

Research, Planning, Development Consulting Services August 2013 to June 2014

International consulting for Quality Systems, Audits, FDA Compliance and Remediation, including: Abbott Vascular (catheters & endoscope material supplier qualifications, Temecula, CA and Costa Rica); Enhanced Filter (ISO13485 audit and compliance consulting, Ventura, CA); Atrium (third shift production monitoring and SPC, Hudson, NH), Philips Medical (field complaints, CAPAs, supplier quality, Cleveland, OH), Philips Lamps (established DHF, QSRs and FDA audit preparation, Eindhoven, Netherlands).

ORCHID Orthopedic Solutions, Arcadia, CA Quality Manager July 2012 to August 2013

Contract manufacturer for orthopedic titanium and stainless steel implant products. Determine QA & QC procedures and manage inspection and quality engineering teams, reduction of scrap and Lean Manufacturing implementation; FDA site registration, production site transfer and validations; Management Representative; development and review of quality metrics; ISO9001/ISO13485 & 21CFR820 regulatory compliance; CAPA and customer complaint management, MRB chair; lead auditor, supplier assessment; Risk and Environmental Health & Safety, harmonize corporate procedures. (Position eliminated with plant consolidations).

WILLIAM A. DeVROOM 909-***-**** / ad112p@r.postjobfree.com / page three

EXPERIENCE HIGHLIGHTS, cont

Research, Planning, Development Consulting Services September 2004 to March 2012

Contract/Consulting services, including: Alcon Labs (Irvine, CA), Apricot Designs (Covina, CA), Helix Medical (Baldwin Park, CA), ResMed Motor Technologies (Chatsworth, CA) - Implemented Engineering Documentation Control (EDC), Project Management planning and reporting. Manufacturing Engineering in development of production methods, assembly fixtures, IQ/OQ/PQ validation, and documentation for ophthalmic surgery and drug delivery devices. Quality Engineering for plastics injection molding, Gage R&R, SPC and process capability.

Prepare specifications, test protocols; ISO9001/ISO13485, ISO60601-1, ISO14971 risk and regulatory design compliance; coordinate medical respiratory PAP development for operations in Sydney and US with flow generator mechanical, electronic, acoustics and mask/ventilation groups. Concurrently, University of LaVerne, DeVry University – adjunct teach MBA courses in Project and Quality Management, International Business and Marketing, Contract Negotiations, and Change Management.

GENZYME Pharmaceuticals, Cambridge, MA July 1998 to June 2004

Associate Director Business Development, synthetic lipids, peptides, drug delivery technologies. Performed 60% travel to customer accounts in the Americas, corporate office in Massachusetts, UK international office, and Switzerland production plant. Drove sales from $2.5 million to $7 million while growing customer base from 15 to over 100 accounts. Developed marketing plans and sales materials; product pricing; sales presentations to customers, negotiated contracts and licensing agreements; attended domestic and international trade shows. (Division sold with corporate restructure).

SUNRISE MEDICAL, Bio Clinic Division, Ontario, CA February 1996 to June 1997

Director of Engineering

DME support surfaces and controls for decubitus ulcer market product and safety analysis development. Won “Sunrise Corporate Speed Award” for bringing product concept to market in only 6 months’ time and resulting in 45% sales growth for the control unit product line. Led redesign of product line to meet changing market needs, capturing 10% market share. Negotiated vendor supply agreements, conducted supplier field audits, determined alternate site and make-buy decisions and streamlined manufacturing processes achieving 15% cost savings. (Bonus provided for managing plant closure).

FIDUS MEDICAL TECHNOLOGY, Fremont, CA 1993 to 1994

Director, Regulatory Affairs, Quality Assurance and Technology Development

Start up medical device company through early Clinical studies for Radio Frequency (RF) catheter used in heart ablation therapy. Report to President. Conducted FDA submission of 510k. Prepared V&V study protocols, conducted testing, surgeon interface and communications with FDA Reviewer.

CYGNUS THERAPEUTIC SYSTEMS, Redwood City, CA 1992 to 1993

Manager, Manufacturing Technical Services

Production process development and V&V for transdermal pharmaceuticals nicotine and fentanyl--- increased yields by 27% and cost savings of 15% (achieved efficiency objectives, but inventories overstocked from over optimistic market projections)

BAXTER HEALTHCARE CORPORATION February 1990 to June 1992

Director Quality Leadership Process & Program Director - Baxter Novacor Division, Oakland, CA

Directed $4.2 million National Institutes of Health contract for first fully implantable artificial heart system, directed 40-person team performing integration of R&D, RA/QA, Marketing, and Manufacturing functions. Launched TQM and Product Development processes (PDP), and directed CIP teams based on Kaizen/Deming principles. Prepared technical package for PMA FDA submissions

Program Manager - Baxter Technology & Ventures Division, Irvine, CA

Directed new technology development and product launch for urology and gastroenterology product lines including regulatory submissions, marketing, manufacturing, and clinical studies. Ran GMP production start-ups in U.S. and Europe, including MTBE drug aseptic sterile fill process that opened up new markets.

Prepared technical packages for 510k FDA regulatory submissions.

WILLIAM A. DeVROOM 909-***-**** / ad112p@r.postjobfree.com / page four

EXPERIENCE HIGHLIGHTS, cont

ALCON Labs, Surgical Instruments Division, San Leandro, CA December 1987 to February 1990

Engineering Manager. Developed electro-mechanical ophthalmic instrumentation equipment and related disposables with design controls, and product safety risk analysis. Supervised staff of 30 and directed outside research contracts. Conducted market research, specified, designed, and developed products for posterior ophthalmic surgery; medical consumables and mechanical devices leading to 8% market growth.

Prepared technical packages for PMA, 510k FDA and foreign regulatory submissions.

IOLAB (Division of Johnson & Johnson), San Dimas, CA. September 1982 to May 1984

Section Manager - New Product Development, Testing and Packaging

Designed and directed development of intraocular lenses, related instrument, and disposable products that contributed $10 million in sales. (J&J corporate Tylenol tragedy affected cutbacks and division closure).

Prepared technical packages for 510k FDA regulatory submissions.

BAXTER HEALTHCARE CORPORATION, 11/1976 – 3/1981

Senior Engineer - Pharmaseal, Research and Business Development Dept., Glendale, CA

New product specification and development. Designed patented cardiac monitoring device contributing $6 million in sales. First to convert and validate sterilization method from EtO to gamma radiation saving $10 Million annually.

Biomedical Engineer - Baxter Corporate Biomedical Engineering Group, Round Lake, IL

Patented medical device designs for inhalation therapy, urology, gastroenterology contributing over $10 million in sales; Developed sterile form-fill-seal blow molding process; served as international engineering liaison.

GENERAL ELECTRIC COMPANY, 11/1973 – 10/1976

Engineering Management Training Program (EMP) and Engineering “A” Course (M.S. equivalent)

GE corporate program with graduate courses, seminars, and rotating assignments in product and equipment design, process control, testing and manufacturing engineering for: Medical Systems (Wisconsin); Medium Steam Turbine & Gear (Massachusetts); Housewares (Pennsylvania); Lamp Materials (Ohio).

Other: consulting for A&W BOTTLING, CALIFORNIA MICROWAVE, CASCADE EARTH SCIENCES, EYEMETRICS, CILCO, MARKEY MACHINERY, RAINBIRD, WATERJET, XTECH MEDICAL, 1981-1982, 1984-1986, 1992-1996

Medical Product Summary

Ophthalmic expertise with Alcon Labs surgical equipment; IOLAB/J&J, CILCO intraocular lenses; Eyemetrics - glasses

Cardiovascular and Neurovascular expertise with Baxter, Stryker, Fidus, J&J

Gastro-Intestinal expertise with Baxter, J&J

Respiratory Therapy expertise with Baxter, ResMed

Orthopedic expertise with University of Pennsylvania, Orchid Orthopedics

Pharmaceutical expertise with Genzyme, Alcon Labs, CILCO, IOLAB/J&J, Cygnus Therapeutics

Additional experience information available upon request.

WILLIAM A. DeVROOM 909-***-**** / ad112p@r.postjobfree.com / page five

EDUCATION

CLAREMONT GRADUATE SCHOOL / UNIVERSITY MBA, Program Management (Peter Drucker)

Claremont, CA and Market Research (James Meyers)

UNIVERSITY OF PENNSYLVANIA BS, MECHANICAL ENGINEERING

Philadelphia, PA and pre-Med completion with graduate studies in

Biomedical Engineering

General Electric, Engineering Management Program Engineering “A” Course

(Lehigh, U of U, etc, 3+ years graduate studies) MS equivalent, Graduate Engineering courses in

Controls, Design of Experiments, Materials Science, Biomedical Engineering, program completion

(at various universities)

OTHER

Lean-Six Sigma Black Belt Certification (New Horizons, 2011)

ISO 9001 / ISO 13485 Lead Auditor RABQSA Certification (AQS/Axeon, 2012)

EU MDR Training (Exemplar Global/Axeon, 2020)

EMT-1 Paramedic Certification (Illinois)

Kepner-Tregoe course (Illinois)

BSA Eagle Scout, Wood Badge, Scout Leader service as Cubmaster, Scoutmaster & District Commissioner

Computer Applications: ProE, Solidworks, AutoCad, Excel, Word, Power Point, Access, MS Project, Minitab, Visio, Paradox, dBase IV, JD Edwards, SAP, M2M, Oracle and programming in BASIC, FORTRAN, C

Member, American Society for Quality (ASQ)

Member, American Society of Mechanical Engineers (ASME)

Member American Association of Pharmaceutical Scientists (AAPS)

Patents: Hemodynamic Pressure Monitoring/Catheter (US4515278, US4428383, USD275233, USD277165); Diagnostic Reagent Dispensing (US4234103); Respiratory, fluidic devices (USD258910, US4676894, USD277165)

Adjunct Professor: California State University (Hayward); Chaffey Community College; University of LaVerne; Keller Graduate School of Management, DeVry University – taught graduate courses in Project and Program Management: Risk Management; Managing Quality; Marketing and International Marketing Management; Managing in a Global Economy; Negotiations; Strategies in Change Management; Global Business Management

Consultant Instructor, Exemplar Global/Axeon: ISO9001:2001 Quality Management; ISO13485:2016 Medical Devices’ EUMDR; Corrective Action and Root Cause (ISO14971)

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