Mark Eberhardt Email & Phone Number

Elverson, Pa, Us

Exton, Pennsylvania, United States

Develop, execute, and lead the strategy of CZ Containment Systems R&D sustaining organization assuring correct balance between, documentation, engineering work and support of business opportunities.

Exton, Pennsylvania, United States

Lead an engineering team bringing new solutions to the pharmaceutical container space

Norristown, Pennsylvania, United States

Responsible for all aspects of Product development, Design control, and Regulatory Compliance for the company's trans catheter aortic valve.

Whitemash, Md

Managed the newly created Futures Team of 6 employees until business unit closed.

York, Pa

Led the launch of the division’s first digital product and workflow allowing dentures to be designed in digital space and manufacture on a variety of existing dental milling machines.Led design of digital ready denture teeth which allow “plug and play” assembly required for 3D printed denture solutions instead of traditional hand fitting.Led work to identify key functional considerations and requirements to allow proper function of 3D printed dentures. Identified and Developed relationships with strategic partners to get new products working and supported on new and existing hardware platforms.

Elton, Md

Led project engineering teams of 4-8 engineers providing technical leadership, guidance, and analysis coaching and skills development to team members resulting in the development of a new global product platform and platform roll-out plan.Led Voice of Custom and clinical feedback study designs and execution resulting in new standards that were adapted by the corporation globally.Project manager and project technical leader on 2 successful products taking them from VOC (voice of the customer) through launch including all scheduling, budgeting and implementation details.Responsible to oversee all project documentation including DHF (design history file) creation and completion, design verification, and validations and required change orders. Responsible to oversee all project engineering activities including the development and qualification of lab tests for characterization and design verification, root cause analysis and solution implementation.Completed 6 sigma black belt trainingPatents: US9566413B2 issued, 5 patent applications pending

Managed 11 engineers, technicians, co-ops.Led the designing and developing the mechanical technology for products and product improvements of the company’s endovascular line including design of housings, pumps, valves, syringes, balloons, guidewires, and catheters within time and budget requirements Responsible for the product development laboratory management including equipment specification and procurement as well as overseeing the layout and fitting of laboratories improvements including a full re-design during a company relocation to a new facility. Responsible for the engineering review and disposition of Non Conformance Report (NCR) and Corrective Actions (CA) and Engineering Change Notices (ECN).Led multi-discipline project development teams from brain storming to product launch including planning, budget, specifications, documentation, Failure Mode Effect Analysis (FMEA), prototypes, feasibility testing, pilot builds, verifications, validation, aging studies, animal studies. Led the design of assemblies using injection molded, extruded, drawn, machined, welded, glued, and soldered components requiring extensive research to determine appropriate materials, suppliers and assembly methods. Conducted analysis of designs using FEA and spreadsheet calculations and well as getting assessments from physicians and clinicians. Proficient with Solidworks and ProE. Patents issued: 8267871, 7976528, 7803124, 7666161, 7226425, 7048696, 7004914, 6902535, 8,920,402

Performed research and development related to PEM (proton exchange membrane) fuel cells on a grant funded research project with the goal of creating a consumer product. Designed, analyzed, and tested prototype systems, test equipment and test plans.Supervised team of technicians during equipment builds and test plan implementation

Developed process/equipment changes to improve quality, yields, and manufacturability while maintaining safety, efficacy, and FDA compliance of the product. On-loaded new products from the development group including completion of process validations, equipment qualifications, writing production instructions, in process specifications, and Operator training. Provided engineering support to manufacturing relating to centerless grinding, RF and ultrasonic welding, braiding, coating, extrusion, resistance welding, bonding, and assembly. Determine disposition of product or materials with some discrepancy from specification and recommended corrective actions to prevent a reoccurrence. Patents issued: 7524301, 6663588

Bsme, Mechanical Engineering, 3.7/4.0

Education record