Michael Mcgurk Email & Phone Number

Monroe Township, Nj, Us

Moorestown, Nj, Us

Quality Engineering & Compliance:Developed purchase specification templates and inspection sheets utilizing statistical methods to ensure product quality control.Authored nonconformance reports and executed corrective actions, including 3D-printed solutions for component nonconformance.Spearheaded compliance programs for Prop 65, Conflict Minerals, packaging data, and USMCA certifications.Manufacturing Engineering:Conducted tolerance analyses and improved cost-effective production workflows.Provided input on new product development and consulted on design improvements.Led discussions on gaging and tolerancing to ensure alignment with manufacturing capabilities.Facilities & Equipment Maintenance:Diagnosed and resolved manufacturing equipment issues, including fabricating a stamp press delay switch that negated a $7k replacement, compressors, ventilation systems, and label printers, and pallet rack safety and complianceVendor and Offshore Supplier Relations:Maintained technical communications with Taiwanese suppliers to ensure product quality and delivery timelines.Developed inspection protocols for inbound goods and collaborated on production optimization.Regulatory Documentation:Compiled and responded to regulatory requests for product data, certifications, and design rationales.Product Repairs & Data Analysis:Evaluated and Repaired returned product, determining root cause, warranty coverage, and handled customer relationsEnhanced complaint logging by implementing occurrence tracking codes.Created improved templates for repair analyses, leading to actionable insights.

Bridgeton, Nj, Us

Led international outsourcing initiatives, achieving substantial cost savings: Optimized procurement, reducing costs for Brass Nipples (2.75") by 70-84%. Negotiated average savings of 40% on components such as Hand Launcher Head, Hand Launcher Locking Ring, Hand Launcher Handle, and 4.5" Nozzle, saving over $20,000. Redesigned the Capsule Dispenser Stand, cutting costs by 44% and saving $12,000.Designed a Modular Launching Nozzle, increasing profit margins by 60%, reducing costs by 80%, and leading to a patent application. Defined product line succession strategy for Carousel AutoLoader releases, ensuring seamless integration. Collaborated with an electronics engineer to design industrial hose and tube cleaning systems using HMIs, PLCs, mechatronics, automation, and pneumatic components.Oversaw maintenance and repairs of manufacturing equipment, including capsule manufacturing machines, packaging equipment, and industrial 3D printers. Created an inventory management system for spare parts. Implemented rigorous quality control and documentation practices, maintaining high standards through product support and feedback logs, raw material quality tracking, film and projectile quality logs, packaging machine maintenance plans, software version history logs, and semantic versioning for software updates.Contributed to electronics assembly and support for wireless barrel setup and sensors. Optimized supply chain operations by renegotiating prices and improving procurement processes, lowering production costs and enhancing cost-efficiency.Fostered relationships with international suppliers, negotiating favorable terms. Represented the company at international industry events such as Tube Expo in Dusseldorf, Germany. Provided field support visits to solve technical issues for customers in the USA and int'l. Used SolidWorks for design, modeling, and drawings. Identified and corrected errors on pneumatic schematics, product drawings, and product manuals.

Raynham, Ma, Us

Led the design and development of new implants and instrumentation and supported in-market products through their product life-cycle within a cross-functional project team. This included communication with surgeons and sales consultants, understanding of clinical issues, defining the design parameters, and ensuring the correct product is provided to the customer.Responsible for the Research and Development (R&D) aspects of a project, participating on cross-functional project teams through all phases of the product life-cycle, and assisting the project leader with planning and executing projects or portions of a project through product launch, commercialization, and post market surveillance. • Technically led design and development projects with oversight, and worked closely with the project leader, members of the project core team (marketing, manufacturing, quality, testing, supply chain etc.)• Engaged surgeons to define user needs and design inputs• Solved design problems utilizing CAD techniques, rapid and conventional prototyping and other available technologies• Developed layouts and tolerance studies utilizing GD&T, and will participate in performing design evaluations (such as FEA, simulated use testing, dry labs and wet tissue labs etc.)• Developed and executed design verification/validation plans, test methods and protocols, and supported regulatory processes for global registration efforts• Worked with manufacturing engineering and/or suppliers to optimize designs for manufacturability and assembly to produce functioning prototypes and supporting production documentation• Demonstrated proficiency in the application of design controls and development processes, and support the project leader with aspects of the project management functions including scope definition, and contingency planning.• Performed quality/compliance activities in support of audits, remediation projects, non-conformances, regulatory compliance projects.

Raynham, Ma, Us

I designed surgical instruments and implants to be used in orthopedic surgery.• Developed and constructed prototypes, evaluation of clinical needs, development of functional and design requirements, perform verification and validation tests and compile reports, perform risk hazard analysis, write engineering rationales, evaluate product complaints, and processing nonconforming product reports • Designed and develop new implants and instrumentation• Engineered improvements and modifications to current products• Created mechanical test protocol (strength and fatigue tests according to American Society for Testing and Materials - ASTM) standards and coordinate the activities required to fabricate test parts and perform mechanical testing• Developed and maintained necessary product design control documents according to government standards for new and released orthopedic medical implants and devices according to design changes, surgeon feedback, and adherence to regulation changes, in order to consistently improve patient care• Performed the required activities and generated the appropriate documents to ensure compliance with Food and Drug Administration (FDA) Design Control regulations, and to support 510(k) submissions and Investigational Device Exemption clinical studies• Coordinated with suppliers to ensure quality standards• Supported AO Foundation sponsored surgeon training conferences around North America• Mentored new interns and co-ops

Raynham, Ma, Us

R&D co-op responsibilities to assist with:- Existing product changes- CAD mode and drawing updates-New Product Concept investigation- Product portfolio and business training

I was the consulting engineer for two large sculpture art projects that were constructed for an art festival in the Nevada Desert. I was consulted by the head artist for structural design and planning. I also worked on-site to facilitate and troubleshoot construction. Challenges of building large scale art in the desert include extremely high winds, variable weather conditions, and limited building supplies.