Joseph Markham Email & Phone Number

The technical specialist’s primary responsibility is auditing orthopedic and dental companies applying for medical device certification marketed in Europe and the United Kingdom. Audits of technical files for class III, IIb and IIa medical devices which cover in-depth examination of design specifications, verification and validation tests, risk management system, post market surveillance and clinical data. The scheme manager role entails managing and supporting client’s medical device portfolio with scheduling yearly audits to maintain CE, MDR and UKCA certification in Europe and the United Kingdom.Currently holds technical specialist codes for auditing orthopedics devices and scheme management codes for CE, MDR and UKCA schemes

Parsippany, Nj

Serve as lead design engineer for TM Ankle Fusion Spacer and TM Ankle Interpositional Spacer systems.Define user needs and design inputs through coordination efforts with the Developer Surgeon Team.Conceptualize implants and instruments using Next Generation (NX) Unigraphics which came from the developer surgeon’s input.Display competency in leading the development of the project from conceptualization to manufacturing.Expertly manage the Validation Cadaver Laboratory to ensure that all product validation requirements were met.Act as key contributor to the Design History File (DHF) Remediation Project, in charge of leading the Contract Engineering Team for all TM Hip and Spine product lines.Render full oversight on project remediation that includes classifying and closing validation and verification gaps for changes in engineering for drawings, manufacturing specifications, surgical techniques, labels, and product inserts.Utilize keen eye for detail in determining missing risk elements in surgical techniques, labels, and product inserts.Demonstrate skills in drafting the design control trace matrix (DCTM) for all product lines, covering all design controls elements including user needs, design inputs and outputs, acceptance criteria for validation, and proof of verification and validation.Preside over design review meetings regarding planned gap resolution and closures.Key Highlights:Played an integral role in developing ankle fusion spacer platforms for ankle fusion and revision surgery on failed total ankle implant.Made significant contribution in the release of TM Ankle Fusion Spacer and TM Ankle Interpositional Spacer in Europe within the first quarter of 2013.

Took charge of mechanical testing on scalpel and surgical blade product lines.Wrote shelf life test protocols to validate safety and performance.Documented written reports on testing through the design history file with Research and Development (R&D) and Quality approval.Performed safety testing to guarantee support on shelf life claim on scalpel and surgical blade product lines.Created the sharpness test equipment for surgical scalpels.Led the design of prototype fixture to simulate actual blade incisions in surgery, as well as to accommodate numerous scalpel blades and cut angles.Handled the preparation of numerous surgical blade foil packs which varied on peel strength and package size used in the marketing survey to more than 60 nurses.Key Highlights:Served as key contributor to the marketing study for surgical blade packaging, which included foil packs presented at the AORN 2010.Effectively supported developments to surgical blade packaging through the results of the survey and directly based on the voice of the customer.

Steered efforts in developing surgical and restorative instruments for dental implants.Conceptualized the design of all parts and assemblies in SolidWorks 2008, which included abutments, transfers, analogs, implant drivers, and product packaging, as well as test fixtures and equipment recommended for small laboratory use.Assumed full responsibility in executing the following:- Writing thorough procedures of restorative systems;- Discussing all designs with other engineers, quality, and marketing personnel;- Designing and creating layout of surgical and restorative trays and kitsInterfaced with clinicians regarding surgical and restorative systems for customer feedback while executing product improvement for the customers’ needs.Authored mechanical test protocols for surgical system to test safety and performance Facilitated mechanical testing and documented summaries of detailed test and provided effective recommendations to product design both based on testing results.Initiated tray designs following system needs including process flow, instrument presentation, and customer input.Acted as point of contact to tray vendors, in charge of procurement, production, quality control, and sterilization testing.

 Held accountability in documenting test protocols, instructions, and reports, as well as fixtures designing for testing in SolidWorks 2007. Employed engineering expertise in validating scalpel and surgical blade product lines for CE mark requirements, which included accelerated aging and real age testing, and updating packaging with CE mark graphics.

 Administered the mechanical design for optical and cable television (CATV) products and custom analog projects. Managed the design of all parts and assemblies in Pro/ENGINEER Wildfire, which involved housing, heat sinks, faceplates, wire harnesses, and printed circuit board (PCB) outlines. Adhered to all product designs by developing and conveying to manufacturing. Efficiently dealt with the design test and assembly fixtures for all product lines.

Developed specialized surgical tools and fixtures for pelvic, femur and knee trauma. Designed all parts and assemblies in Pro/E Wildfire; including drills, bone depth gauges, bone alignment and fixation devices. All designs coordinated with other engineers, surgeons and marketing teams.Coordinated prototype instrument trays and surgical kits for current products. Responsible for tray layout, screw racks and graphics.

Developed optical repeater CPCi rackmount system. Designed all parts and assemblies in Pro/E; including heatsinks, faceplates, PCB outlines, EMI shields and backplane connector system. Responsible for mechanical layout, thermal management of the rackmount system, optical tray and repeater cards. Coordinated all efforts for procurement, production, quality control, reliability and environmental testing of the system.Responsible for transponder product line mechanical development; 10 gigabit 300-pin transponders included: flat-top, heat-fin and small-form factor designs. Design components included housings, PCB outlines, EMI shields, inter-connectors and conforming materials.Coordinated outsourcing for PCB assemblies. Responsible for qualifying all PCB assembly vendors. Organized consigned materials, design specifications and quality requirements.Designed and built fixtures for soldering, desoldering, assembly and test, for transponder product line. Responsible for maintaining, programming and training technicians on in-house equipment such as the BGA rework station, convection oven, screen printer and machine shop tools. Worked with managers, engineers and technicians to optimize process flow documentation.Supported manufacturing and production for transponders, lasers (EML's) and receivers departments. Responsible for documenting, fixturing, machining and failure mode analysis on the following processes: SMA and TH soldering, laser welding, die attach, wire bonding and seam sealing.Was key contributor to Multiplex ISO 9001 certification. Finalized transponder, laser and receiver documents throughout manufacturing process. Drafted part and assembly drawings, procedures, bills of materials, travelers, process flow charts and engineering changes orders for document control.