Shawn F. Hogan Email and Phone Number
Shawn F. Hogan work email
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Shawn F. Hogan personal email
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• Engineer (Bachelor of Science, Plastics Engineering, UMASS - Lowell)• Lean Six Sigma, Certified Green Belt• Medical device engineering professional with expertise in high volume manufacturing, regulatory and quality assurance, polymer materials and processing, sales, and intellectual property law.• Specialties: Medical device engineering; Full cycle manufacturing; FDA 21 CFR 820, ISO 13485 / 9001, and GMP requirements; Lean Six Sigma; FDA audit observations and responses; Process and Product development / validation; Design and Process Failure Modes Effects and Criticality Analysis (DFMECA / PFMECA); Non-Conformance investigation and resolution; Corrective and Preventative Action plans (CAPA); Continuous Improvement (CIP) Studies / Evaluation builds; Product rework and waste reduction; Process scale-up and Technology transfer; Equipment installation and qualification (IQ, OQ, PQ); Critical property testing; Engineering, manufacturing, and quality documentation (ECR / ECO); Plastics Engineering; Polymer materials and processing (compounding, extrusion, injection molding, thermoforming); Key metric tracking; Tooling and fixture validation; Vendor selection and qualification; Competitive product evaluation; Sales / Domestic and International account management; Intellectual Property (procedure, patent applications / prosecution, landscape and portfolio analytics); Competitive intelligence / Emerging and Disruptive technologies; Licensing.
Medtronic
View- Website:
- medtronic.com
- Employees:
- 10
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Senior Manufacturing EngineerMedtronic Nov 2018 - PresentMinneapolis, Mn, Us
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Senior Manufacturing EngineerGetinge Mar 2015 - Oct 2017Gothenburg, Se• Provided engineering support for Thoracic Drainage, Endovascular, and Biosurgery product lines.• Primary lead for investigation and resolution of manufacturing and packaging non-conformances. » Recognized for successfully closing over 300 non-conformance reports (NCR) across multiple product lines. » Departmental representative for weekly Material Review Board (MRB) meetings. » Assigned to various CAPA teams to assess and take remedial action to eliminate non-conformances in accordance with FDA 21 CFR 820 and ISO 13485 requirements. • Assisted with coordinating relocation of Endovascular Packaging from Hudson campus to Merrimack campus (IQ, OQ, PQ). » Trained operators to new processes with respect to packaging and label assemblies. » Verified product performance against design inputs. • Updated / created all forms of manufacturing documentation through the ECO process in conformance with FDA Quality System Regulations and ISO standards. » Quality control and inspection specifications, product assembly instructions, component and tooling specifications, validations, packaging instructions, sort and rework protocols, testing and verification reports.• Provided day-to-day technical floor support to Manufacturing Production operations by investigating and resolving issues which materialized during the manufacturing, processing, and testing of products. -
Patent Examiner / Chemical And Materials EngineeringUnited States Patent And Trademark Office 2011 - 2013Alexandria, Virginia, Us• Expertise in formal requirements and legal matters associated with patent examination and prosecution before the United States Patent and Trademark Office (USPTO), European Patent Office (EPO), and the World Intellectual Property Organization (WIPO). • Completed training under the Leahy-Smith America Invents Act (AIA). -
Intellectual Property ResearcherIp.Com 2011 - 2011Fairport, New York, Us• Interpreted patent and non-patent technical literature in order to conduct patentability, validity, freedom to operate (FTO), and business / marketing information searches.• Managed time and docket workload to consistently meet project milestones and deliverable dates. -
Analyst / Search ProfessionalCardinal Intellectual Property 2010 - 2011Evanston, Illinois, Us• Performed a wide variety of patent and non-patent literature searches for private and corporate clients in support of business development objectives. -
Project Analyst / Medical Device And Advanced MaterialsNerac, Inc. 2006 - 2009Tolland, Ct, Us• Cross-functional team member assigned to the Advanced Materials, Medical Device, and Patent Analytics research groups. • Delivered custom assessments and professional opinions directly to clients on a variety of medical, engineering, materials, and business topics.• Consistently recognized for outstanding interpersonal, listening, and communication skills. » Frequently selected by key account managers to travel in support of sales and business development efforts via on-site orientations and presentations. -
Inside Sales Manager / Territory Account ManagerGates Mectrol Corporation 2003 - 2005Denver, Colorado, Us• Supervised and coordinated the activities of the Inside Sales Department (consisting of six direct reports) for global manufacturer of precision timing belts and pulleys.• Directly responsible for Southwest and West Coast geographic sales territories encompassing 17 states.• Monitored, tracked, and reported key metrics of actual versus planned performance to upper-level management. -
Manufacturing Engineer Iii (Plastics)Hologic, Inc. 2001 - 2002Marlborough, Ma, Us• Project Manager for the FirstCyte™ Ductal Lavage System, a diagnostic device used for early detection and risk assessment of breast cancer. » Directed the efforts of numerous internal and subcontracted teams in executing company acquisition. » Leadership role in due diligence and integration to ensure regulatory compliance with all FDA and ISO requirements. » Successfully coordinated a cross-country relocation of manufacturing from the West Coast to the East Coast.• Provided engineering and quality assurance support for medical diagnostic applications and disposable products primarily focused on women's health. » Involved with sustaining manufacturing for ThinPrep® Pap Test product line, including injection molding and pick-and-place robotics for assembly and labeling / packaging of components. -
Product Support Engineer / Inside Sales Account ManagerBattenfeld Gloucester Engineering Co., Inc. 1999 - 2001• Member of three-person OEM sales team recognized for consistently exceeding sales targets. » Increased sheet extrusion product line sales from 1.8MM to over 10MM in less than two years.• Provided engineering support for company's full line of sheet extrusion machinery and downstream equipment. » Experience with motors, gearboxes, multilayer feedblocks, dies, screen changers, pumps, conveyance, electro-mechanical, and software-driven products.• Quoted and facilitated full line installations, upgrades, retro-fits, technical service visits, equipment demonstrations, training seminars, and in-house lab trials to meet customer business objectives and establish future opportunities.• Represented and promoted company brand at numerous industry conferences and tradeshows, including ANTEC® and NPE, resulting in expanded market penetration / visibility and customer range.• Created and maintained a vendor database to more effectively track and enhance supply-chain management, thereby reducing lag-time between orders, manufacturing, and delivery.
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Senior Engineering TechnicianMedtronic 1995 - 1999Minneapolis, Mn, Us• Member of Extrusion Engineering team focused on development and improvement of cardiology- based product line (PTCA balloon and guide catheters, stent delivery systems).• Effectively served as lead technician and primary interface for FDA QSR, ISO, and GMP documentation and compliance.• Responsibilities included material ranging and validation studies, process development, identifying and implementing corrective actions, manufacturing and quality documentation, complaint handling and device reporting, equipment installation and qualification (IQ, OQ, PQ), critical property and product testing, statistical analysis and reporting, competitor product evaluation and comparison, calibration and preventative maintenance.
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Process Technician / Shift SupervisorPhoenix Polymers, Inc. 1994 - 1995• Responsible for evening and weekend shift operations.• Practical experience with custom compounding of filled resins, alloys and blends (colorants, plasticizers, UV stabilizers, flame retardants, anti-statics, fibers, etc.). » Co-extrusion; material handling and pre-processing requirements; screw profile configuration; pelletizing; equipment and material troubleshooting; all startup / shutdown procedures.
Shawn F. Hogan Skills
Shawn F. Hogan Education Details
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University Of Massachusetts LowellPlastics Engineering
Frequently Asked Questions about Shawn F. Hogan
What company does Shawn F. Hogan work for?
Shawn F. Hogan works for Medtronic
What is Shawn F. Hogan's role at the current company?
Shawn F. Hogan's current role is Medical Devices, Plastics Engineer, USPTO Registered Patent Agent.
What is Shawn F. Hogan's email address?
Shawn F. Hogan's email address is sh****@****ien.com
What schools did Shawn F. Hogan attend?
Shawn F. Hogan attended University Of Massachusetts Lowell.
What skills is Shawn F. Hogan known for?
Shawn F. Hogan has skills like Medical Devices, Medical Device R&d, Plastics Engineering, Product Development, Process Improvement, Process Control, Polymers, Plastics, Materials, Intellectual Property, Patent Prosecution, Extrusion.
Who are Shawn F. Hogan's colleagues?
Shawn F. Hogan's colleagues are Chelsea Hernandez, Danielle Rossi, Catalina L., Reed Kellett, Sigiri Prasanna, Colin Wilcox, Souraya Bouzari.
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