Engineering & Project Manager Management for Thetford LLC.

-Lead and manage product design, testing and marketing efforts from inception to production, including all facets of managing variables related to each unique product launch or problem necessary for project delivery.-Responsible for over 400k in direct billing for project development and/or product management hours to clients in 2023.-Manage marketing, UX and industrial design efforts for each project.-Organization, budgeting, and input for quoting new client projects.-Responsible for tracking team and individual hours related to contract targets and goals. -Management of team members’ priorities and work quality related to expected output from clients.-Design of presentations and management review material for internal and client meetings.-Lead design responsibility on a project-to-project basis.-Directly responsible for material and component sourcing, including but not limited to balancing cost and quality.-Worked on various projects in various industries including Exterior Doors, Electronic Fluid Dispensing Devices, Ultrasound Equipment, Refrigeration Technology.-Responsible for management of complex system development for medical device technology.-Responsible for hands on prototype builds and testing related to each unique project using a variety of shop tools and methods.

-Program manager / Project Coordination for new product suite/system development from inception to production, including all facets of managing variables related to each unique product launch. Specific products: Laparoscopic Needle Driver, Dissector, Grasper, Cautery Hook, Shears.-Developed safe/effective monopolar energy paths for laparoscopic instruments to work universally with monopolar generators (e.g.: MegaDyne, ForceFX) per IEC standards.-Worked with surgeons to develop ergonomically sound dual action, single action and no action handles with custom ratcheting features. -Designed complex cable, pulley and geared systems to activate end effector jaws to mock robotic competitive devices.-Responsible for usability analysis specific to new product design and development.-Collaborated directly with customer/user populations to define key characteristics, ergonomics and features necessary to assure successful design iterations. -Participated in live surgery labs (Ethicon Johnson & Johnson) to analyze prototype operation/functionality specific to the device end use expectations.-Responsible for determining project scope, milestones and timelines and tracking those efforts.-Responsible for budgeting direct and 3rd party report’s time and effort allocation depending on scope and project priorities.-Hired and Managed all facets of 3rd party engineering service (2-5 FTE’s) over duration of projects.-Manage sourcing decisions and recommendations for suppliers, equipment, outsourcing of prototypes and elements of production.-Responsible for design and timely execution of project timelines as set by the board of directors and primary investors and funders (Johnson & Johnson).-Hands on with design, prototype builds and testing of new products.-Responsible for writing and maintaining design history documentation.-Responsible for assuring product compliance with relevant governing bodies including ISO-13485 and IEC-60601 standards.

-New product design from inception to production (over 100 products), including all facets of managing variables related to each unique product launch with two lead inventor patents as linked. Specific Products: catheter securement devices, dressings, circumcision clamps, vaginal speculums, laryngoscopes, twitch monitoring, vascular pressure sensors, body bags, drapes, kit packaging.-Direct interaction with FDA auditors to verify quality system adherence in accordance with ISO13485.-Experience designing and production of injection molded parts.-Experience designing and carrying out IQ/OQ/PQ functions for various medical device assembly methods.-Design and review of FMEA documentation for new and remediated products (design/process/application).-Direct liaison between sales and project managers to assure usability needs are met/exceeded.-Researched and managed installation of 3D printer to product development lab.-Communication and organization of product launch through all departments: quality, regulatory, marketing and manufacturing.-Sourcing and developing materials for new medical system designs.-Proposed, developed and managed a multi-functional digital team used to create animation/graphic content for sales and marketing to launch new product.-Communicating with vendors to develop new processes/products to become more competitive within the medical product market.-Refine current products manufacturing processes and design to streamline cost and end user satisfaction.-Develop test methods to ensure safe/robust product designs.-Directly responsible for troubleshooting/investigating customer complaints on current marketplace products.-Manage Engineering Change Request system and all related documentation.-Manage and develop CAD systems (Solidworks/AutoCAD), drawing templates, operating procedures, and all related documentation.-Owner of two medical device patents.

-Developing fusion, compression, and vacuum molding systems to create a variety of medical quality parts and systems.-Traveling with sales staff to meet with customers to determine needs and recommend solutions related to existing and new product lines.-Design new parts/processes for medical customers around the globe from the concept phase through production. Specific products: Compressed foam barrier over MRI PCB’s, MRI patient positioning foam, custom foam barriers for refurbished MRI coils (GE, Phillips, Siemens), surgical table pads.-Trained as an auditor to assist quality department in auditing internal quality systems in an ISO quality environment.-Refine, define, and troubleshoot process flows to ensure optimal product manufacturing processes and end product uses.-Troubleshoot existing product designs to ensure customer satisfaction and ease of production. -Use complex CAD operating systems to create 2D and 3D geometry for product design and presentation.-Became a certified soldering instructor, hired, trained, and organized soldering technicians within Creative Foam to eliminate the need to outsource costly MRI coil assembly. -Introduced new medical product lines that allowed Creative Foam to drop pool and spa products and remain exceptionally profitable.-Proposed and developed a partnership with Western Michigan University’s School of Engineering to aid with research and development projects.

-Presented to and trained large groups of orthotists and orthotic technicians on new product lines in-house and throughout the United States. -Developed testing methods to determine best end use for products under real world conditions.-Developed new orthopedic product lines and retrofitted existing lines to be more cost effective. Specific products: locking/unlocking knee orthosis activated by foot pressure, knee brace systems, knee/ankle/foot orthosis, hip/knee orthosis, ankle/foot orthosis, custom pediatric helmets.-Used CAD/CAM software to develop custom orthoses and prosthetic sleeves.-Communicated with orthotists and their patients in clinical environments to produce practical and efficient products.-Built and modified custom plaster molds.-Designed custom vacuum molds for prototyping and production.-Developed testing methods to determine effectiveness of current product lines in terms of durability.-Studied biomechanics to strengthen knowledge required to design complex orthopedic and prosthetic devices.-Authored and illustrated instruction manuals for new product designs.