Medical Device Engineering Leadership

Richard J. Gallagher ************@***.*** Page * of 2

**** **** ******, *******, ** 27613 www.linkedin.com/in/richgallagher1 C: 919-***-****, H: 919-***-****

Qualifications for Senior Management in R&D / Engineering / Manufacturing

Offers extensive leadership experience and ownership in global R&D, engineering, and manufacturing of medical products. Adept at building innovative teams, creating budgets, and resource loading projects. Talented leader that motivates teams, provides positive influence throughout the organization, establish focus group activities, creates business development relationships, to discussions with Key Opinion Leaders (KOLs) to grow business, increase sales, and M & A opportunities. Responsible for generating portfolio growth, executing plans on time, while achieving quality objectives and operational achievements to strengthen business development strategies. Skilled in analyzing technologies, intellectual property review, assess licensing opportunities, and create NPD process from concept through commercialization. Received several patents, design and develop 100+ surgical products, such as; sutures, catheters, disposable/reusable minimally invasive surgery instruments, heart pumps, RF technology products, platform technologies, line extensions, and complete hardware/software systems. Expertise spans:

Operations & Project Management § P&L Responsibility § Budgeting § Expense Control § Risk Management

Design Control § Manufacturing Engineering § Continuous Improvement § CAPA § DFMEA § Lean Six Sigma § SPC

Knowledge & Product Transfer § IP Portfolio Management § Regulatory Compliance § Team Building & Mentoring

Purchasing § Outsourcing § Negotiations § Customer & Vendor Relations § M&A Analysis § Conflict Resolution

Career Track

VALIDANT Consulting, Warsaw, IN

Independent Consultant 2016 to Present

Quality Engineering consultant and mentor within the packaging validation team - Project Polaris – Zimmer Biomet.

CAPA - Remediation principal, adhering to ISO 11607-2, part of Production and Process Controls (P&PC) team.

M.D. ENGINEER LLC, Raleigh, NC

Independent Consultant 2013 to Present

Consults on planning, strategy, market assessments, design, capabilities, costs and ROI forecasts.

Evaluated the cardiovascular suture market - producing market analysis report outlining cost opinions, manufacturability, and market potential for a private company in fluoropolymer PTFE suture venture.

Saved~$7.5M/year, on a “Biopsy Grasper” platform product, by redesigning and minimizing the number of components.

Define/outline New Product Development (NPD) business model - “start-up” design team for VC firm, options for adding prototype services, design controls, stage gate product review, and software tools used in the medical device industry.

TELEFLEX MEDICAL (OEM), Raleigh, NC 2000 - 2013

Global Director of Research, Development & Engineering 2009 to 2013

Served in an executive leadership role engaged in the design, development, and contract manufacture of surgical instruments, components, fibers/sutures, combo MD/MP products, catheters, plastic extrusions, screws, and plates. Directed R&D activities, from product concepts through post-market launch. Responsible for engineering activities, new products pipeline, intellectual properties, sustaining engineering, facilities and technology expansion for the OEM division. Wrote and refined design control procedures governing process development. Ensured ISO/FDA/ICH/cGMP compliance. Supplied 510k and CE Mark data to create technical files. Supervised 5-7 direct and 65 indirect reports at seven domestic and international facilities. Identify new technologies/projects to broaden capabilities, creating growth synergy.

Bolstered customer relationships to support $143M in sales, 8.5% growth, and 13% gross margins YOY growth.

Defined and aligned engineering goals to increase revenues $60M+ with gross margins of $25M+.

Generated new business through cross-functional global engineering leadership and active partnerships with sales, business development, manufacturing, quality, regulatory, and vendor sourcing teams.

Increased new customers 15% per year by expanding process/material capabilities and establishing third-party supplier relationships to recapture lost business and otherwise “no quoted” RFQs.

Grew RFQ orders, augmented R&D capabilities, improved product consistency, and delivered prototypes three days post PO acceptance by building prototype centers at each manufacturing facility.

Hired key staff, identified key equipment delivering $3M+ in new revenue, cut $2.7M+ costs, and generated non-reoccurring charges of $2M+ per year, while securing $26M+ in sales (via IP) and saved ~$1M in annual royalties.

Director of Program Management R&D 2005 to 2009

Hired and trained multiple program managers at five facilities. Prioritized and managed the product portfolio pipeline and IP for various platforms and processes while communicating with sales, customers, and senior leadership. Assessed risk-based provisions, identified challenges, removed barriers, addressed complaints, and resolved/escalated issues.

Helped create design control procedures across all Teleflex Medical, including streamlining policies/ procedures to reduce development timelines. Served as team lead/division liaison for SAP implementation project.

Launched first Cobalt Chrome Rod Cutter in the market on time (nine months) and within budget ($150K), offering 50% reduced cutting force with twice the cut-life longevity at the same cost as standard rod cutters achieving ROI with first PO supplying sterility validation helped accelerate time to market by 3-4 months, achieving competitive advantage.

Richard J. Gallagher ************@***.*** Page 2 of 2

6216 Rein Street, Raleigh, NC 27613 www.linkedin.com/in/richgallagher1 C: 919-***-****, H: 919-***-****

Career Track, Continued

TELEFLEX MEDICAL (WECK CLOSURE), Raleigh, NC

Senior Program Manager, R&D 2000 to 2005

Pioneered the program management role producing Hemo-o-lok clips, reusable endo 5mm applier/remover, disposable automatic clip appliers, and reusable clip appliers, including various reusable cardio/thoracic instruments. Maintained project accountability; determined scope, prepared detailed plans, documented processes, created design history files, staffed teams, oversaw design, sourced vendors, and executed development/manufacturing activities from concept through to launch. Interfaced between teams, management, and KOLs. Conducted periodic clinical reviews of product performance to ensure safety/efficacy over the product lifecycle utilizing agile and waterfall techniques.

Played a key role in driving change management, including creating project review dashboards for senior management and instructing the organization in project management practices.

Partnered with physicians/KOLs to create award-winning products, conduct market focus studies, perform animal/ lab evaluations, coordinate launch, and obtain patents/IP; identified post-launch trends/risks.

Served as R&D team leader for Hem-o-lok hemostatic clips, the first plastic clip marketed.

LSI SOLUTIONS, INC., Victor, NY

Director of Engineering 1999 to 2000

Acted as technical architect focused on Sew-Right and Ti-Knot 5mm disposable laparoscopic devices. Defined engineering structure, hired key staff, selected vendors, purchased capital/metrology equipment, and instituted inspection/testing protocol procedures. Outlined and managed project expectations/goals, manufacturing plans, budgets, timelines, and resource allocations. Established design control procedures to fulfill marketing, sales, regulatory, and quality requirements for the launch of new products. Ensured design feasibility, testing validation, manufacturability, and costs were acceptable while meeting FDA/ISO/QSR standards.

Transformed a “think tank” prototype business model into a full-scale design-to-production business model.

Trimmed scrap and defects to less than 5%, resulting in lot consistency of 95%+ for MIM technology; reduced lot variations 30%, which improved supplier relations and quality while boosting on-time delivery to 98%.

Validated both product and packaging design for SR-5 (Sew-Right) and TK-5 (Ti-Knot) laparoscopic disposable devices, including a reloadable suture cartridge for products to be marketed and launched in the US.

U.S. SURGICAL CORPORATION (TYCO HEALTHCARE) 1989 - 1999

Manager of Manufacturing Technologies, R&D 1998 to 1999

Held responsibility for all tooling and equipment used to produce, assemble, and package new products for a company with a portfolio that included the Autosonix Ultrasonic Surgical System, One-Shot AAA, CABG, GIA/TA staplers, Endo GIA 30/60 staplers, Trocar/Ports, Radio Frequency Therapy - BPH, Endo Clip I (DLU/Handle), Endo Clip II, EEA/PCEEA staplers, EEA Sizers, Sternum Buckle, and 2mm Laparoscopic System (Scissor, SurgiTie, Scope, Light Cable). Oversaw 30+ toolmakers, mechanics, engineers, and material PhDs providing NPD pilot manufacturing pipeline support for new products. Negotiated with outside contractors/suppliers while adhering to production/launch schedules and cleanroom standards.

Developed $7M CAPEX budgets, including equipment budgets of $20M for the NPD product pipeline.

Helped grow company revenue $200M+ annually through product and process development/refinement, including assembly tooling and test equipment to enhance launch schedule reliability.

Accelerated development cycles up to 25% by using SMEs for technical-related topics for 25 new programs/products.

Delivered time and cost savings by applying DFMEA, SPC, Lean Six Sigma, and world-class manufacturing practices, which lessened cycle times while enhancing product reliability and first-pass yields.

Cut the development cycle 2-3 months by leveraging broad knowledge of plastics/metals manufacturing processes and facilitating early and continuous supplier involvement practices.

Credentials

MS, Management Engineering (MBA equivalent) – University of Bridgeport Connecticut

BS, Industrial Technologies Manufacturing – Central Connecticut State University

Lean Six Sigma Yellow Belt Certificate – Wake Technical Community College

Leadership Trust – Wake Forest Babcock Graduate School of Executive Management

Program/Project Management Training Course (PMI) – Cadence Program

Management and Leadership Training Program – Fairfield University

Patents: 5,588,579; 5,639,008; 5,758,814; 6,880,699; 7,001,412; WO2005074421 A2

Medical Design Excellence Awards: Gold (Hem-o-lok Ligation), Silver (AutoSonix System, Sew-Right / Ti-Knot)

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