Eric Clasen Email & Phone Number

Franklin Lakes, New Jersey, Us

Franklin Lakes, New Jersey, Us

Princeton, New Jersey, Us

- As the R&D core team member of the NeuroCritical Care Global Franchise Team: o Employed Design for Six Sigma (DFSS) methodology to define and develop new neurosurgical devices for the complex global market. o Enriched the NeuroCritical Care Marketing group with technical expertise and training, including competitive product analysis and benchmarking. o Managed the NeuroCritical Care R&D Engineering group consisting of mechanical, electromechanical and biomedical engineers. o Ensured neurosurgical product availability through vigilance and detail driven sustaining engineering efforts. - Provided engineering analysis of mechanisms, including Root Cause Analysis, Design of Experiment (DOE), Finite Element Analysis (FEA), design and testing support for the Cranial Positioning and Access group.- Performed Lifecycle Management of the Epilepsy Brain Mapping franchise, including DHF remediation and product testing for contemporary regulatory submissions.

Princeton, New Jersey, Us

Ensured the successful concept-through-launch development of a single use, sterile diposable catheter used for intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage:- Applied mechanical design talents using Solidworks to blend market-proven design aspects from an existing device with innovative features and improvements to create a best in class product. - Led (i.e., planned, executed and documented for Design History File and in support of Regulatory Submissions) the following critical project activities:o Product Performance Testing (Design Verification/In-process testing): Created a series of laboratory test methods and apparatus to assess device performance and quality under normal and stressed conditions, including pressure sensing, fluid drainage capability, mechanical robustness and leak testing as well as Magnetic Resonance (MR) compatibility testing.o Biological Evaluation: Devised and managed the comprehensive biological evaluation program for this prolonged contact device (< 30 day brain implant) and its accessories per ISO 10993, including a series of biocompatibility tests and rationales.o Sterile Package Performance Testing and Shelf Life Study: Established that the device packaging provides protection to and maintains sterility of the product through the hazards of handling, distribution and storage up to the point of use, per the FDA guidelines and ISO 11607-1.- Engineering Statistics: Utilized Minitab software to perform statistical analysis of test data, as well as to perform a reliability analysis for a MEMS pressure sensor interconnection issue.- Risk Management: Drove Medical Device Hazard Analysis and DFMEA activities per internal Risk Management Process and ISO 14971.- Strictly adhered to Design Controls as dictated by internal Product Development Process.- Sought and incorporated direct feedback throughout development process from clinicians.

Princeton, New Jersey, Us

- Provided engineering support to the concept-through-launch development of a novel CSF Drainage System, which incorporates an innovative safety valve mechanism to minimize the critical risk of CSF overdrainage.o Solved a particularly elusive, project-threatening component “cracking” problem in the design by diligently employing the Weaver method for Root Cause Analysis. o Developed automated safety valve mechanism test methods and fixtures.- Performed Design Control activities for a multimodality monitoring system (capital equipment), which provides a single touchscreen interface for monitoring multiple neurological parameters, accessing product training materials and storing data. o Structured and executed a thorough Software Validation strategy to ensure data accuracy and integrity, including support for the software regulatory submission.o Product featured on the cover of MD+DI Magazine (November, 2007)- Drove the launch of one of Integra’s first internally developed products–an External CSF Drainage System used to drain CSF from the ventricles of the brain or the lumbar subarachnoid space and facilitate intracranial pressure monitoring.o As Project Manager, aligned and managed a cross-functional Project Team.o Distilled and translated existing, conflicting product requirements into a coherent Product Specification document.o Engineered design improvements, including redundant safety mechanisms. o The device became Integra’s flagship CSF Drainage System, demonstrating strong sales with product revenue that outpaced expectations.

For this product development consultancy, specializing in serving the medical and defense industries, and with customers ranging from startups to Fortune 500 companies:- Participated in over a dozen programs for the medical, biotechnology and defense industries, ranging from next-generation electro-mechanical surgical devices to a sample preparation device for a hand-held PCR biological agent detector to cell/tissue culture and blood processing.- Performed mechanical design and drawing detailing including Geometric Dimensioning and Tolerancing (GD&T) in Pro/Engineer.- Product Design: Gathered and applied critical knowledge pertaining to technology/application, market, materials and manufacturing processes to generate technical specifications and design constraints. Maintained sensitivity to time, cost, risk and customer needs.- Generated mechanical concepts and detailed designs in Pro/Engineer for large, mechanically complex assemblies as well as for “simpler”, elegant (typically disposable) assemblies. Examples include:o A functional prototype motor-driven, three axis micropositioning stage for a confocal microscope for noninvasive optical biopsy of the skin.o A functional concept model autoclave-able CCD camera for an endoscopic vessel harvesting device. - Materials: Broad knowledge, with experience in the areas of surgical, cell/tissue culture, PCR sample preparation, and blood processing.- Customer Relations: Interfaced with wide variety of customers, including senior management.- Business Relations: Identified, evaluated and selected vendors for various manufacturing processes and subsequently managed their efforts.- Selected by program managers to participate in the most challenging projects awarded to the firm based on outstanding performance and technical merit.

For this biomedical technology development firm,- Provided concept-through-manufacture engineering of novel medical devices ranging from blood processing equipment to hand-held devices to disposables/consumables.- Research and Development: Member of a team of engineers and chemists striving to apply new or existing technologies in novel ways. Provided engineering support and designed custom experimental apparatuses. Planned and performed experiments to examine the effects of parameters (geometry, materials, temperature, etc.) on device performance and reproducibility.- Generated project timelines, including Gantt charts for mechanical subsystems.- Adhered to regulatory design control standards necessary for FDA submission, including the authoring of technical specifications and organization of technical design data.- Marketing: Rapidly generated proposal drawings, slides, diagrams, renderings, animations or stereolithography models that well-exceeded management and client expectations. Participated in pre-contract negotiation meetings and presentations to improve customer confidence in firm.- Located and managed vendors for machining, injection molding, and other components.- Leadership: Provided mentoring to new hires and less-experienced coworkers.- Diplomacy: To promote constructive cross-functional working relationships and maintain project momentum, served as liaison between engineering, chemistry, marketing, and management personnel. Listened to and understood the needs and concerns of each party involved, proposed and mediated discussions, and developed a plan of action.

For this world leader in parking equipment, traditional time clocks, and automated time and attendance software solutions:- Designed, from concept to working prototype, an enhanced version of an existing time recorder with sales exceeding 30,000 units per year.- Created solid models of each new part for rapid prototyping by stereolithography.- Trained colleagues to make use of modern computer-aided design tools.

Master Of Science (Ms), Mechanical Engineering

Bachelor Of Science (Bs), Mechanical Engineering