Jason K. Email and Phone Number
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• Experienced and dynamic program manager with PMP certification, technical background, and >20yrs successfully leading diverse cutting-edge technology projects, both hardware and software in an FDA regulated medical device environment.• Proven success in managing complex projects with multi-functional international teams including requirements, scope definition, budgets, schedules and deliverables throughout all phases of the product development lifecycle.• Strong track record in maintaining, improving, and extending the lifecycle of medical products in a challenging supply enviroment.• Background in electrical engineering with extensive knowledge in design of specialized systems and complex electromechanical medical instrumentation and accounting for cybersecurity needs.Specialties:Program ManagementPMP Certification - PMI InstituteProduct Lifecycle ManagementNew Product Development and IntroductionCybersecuritySystems EngineeringSustaining Engineering / Product SupportMedical Devices & Certifications - ISO13485, 14971, 510(k)Quality Control
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Program ManagerWerfen North America 2012 - PresentBedford, Ma, Us• Manage and lead complex projects focused on sustaining and extending product life-cycle including product improvements, customer issues, and component obsolescence.• Lead multidisciplinary teams on projects involving in-vitro electro-mechanical instruments and software systems.• Collaborate with product marketing to define product requirements and specifications, ensuring that functionality aligns with customer desired features.• Extensive interaction with both domestic and overseas suppliers and manufacturers in order to maintain product quality, leverage cost savings, and ensure stable supply.• Lead team in supporting company’s largest site installation of flagship laboratory automated system.• Utilized knowledge of risk analysis, regulatory requirements, and FDA 510k processes to support maintaining and obtaining updates to product certifications.• Extended lifecycle of large automated blood analyzer product line to continue providing customer support and ongoing revenue from consumable reagent materials.• Performed scheduling and resource management to ensure timely completion of projects within budget while meeting performance metrics.• Work closely with cross-functional engineering teams on product development, prototyping, verification, and transfer to production.• Work closely with field and customer service organization for investigations and prioritization to resolve issues.• Manage multiple simultaneous projects, adjusting priorities and available resources as needed to achieve positive outcome.
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Sr. Engineering Project ManagerNds Surgical Imaging (Formerly Planar Systems And Dome) Jun 1998 - 2012Sarasota, Florida, Us• Responsible for project lifecycle from requirements and concept to implementation and product release, thereby sustaining a cohesive development environment.• Collaborated with product marketing to define product requirements and specifications, ensuring that functionality aligns with customer desired features.• Extensive interaction with overseas suppliers and manufacturers in order to maintain product quality and leverage substantial cost savings.• Served as primary engineering contact for multi-disciplinary teams across site locations, including training and troubleshooting support.• Utilized knowledge of risk analysis, regulatory requirements, and FDA 510k processes to obtain certifications and approvals for new products.• Performed scheduling and resource management to ensure timely completion of projects within budget while meeting performance metrics.• Served as project manager and systems engineer for development of the world's highest resolution grayscale LCD monitor which was showcased at an industry tradeshow.• Maintained both supplier and internal change control and support for recently released and mature products.• Implemented new processes to improve cross-functional collaboration and accelerate development cycle, thereby positively impacting project outcome.• Worked closely with engineering teams on product development, prototyping, verification, and transfer to production, including sustaining engineering for extended product life.NDS acquired the medical division of Planar in 2008. -
Engineering Project ManagerPlanar Systems Apr 2003 - Jul 2008Hillsboro, Oregon, Us• Served as project manager and systems engineer for new product development of high resolution medical devices and displays.• Expanded role as project manager to include gated NPI process and management of international teams.• Recognized with company award as key contributor to extending the lifespan of mature products that enabled additional sales revenue in excess of $350,000.• Performed specification definition, design, and verification of multiple custom LCD interface boards and systems.• Implemented cutting-edge technology and compact high performance design with first to market features to enhance the product brand name.• Supported supplier qualifications and implementation of process improvements.Planar Systems acquired Dome in 2003. -
Hardware EngineerDome Imaging Systems Jun 1998 - Apr 2003• Hired as intern during college and transitioned to full time at graduation.• Served as Electrical Hardware Engineer for board and systems level design of high end electronics and devices used in the medical field.• Extensive design, verification, and debug of high density circuit boards and specialized LCD monitors.• As part of a team, pioneered the introduction of LCD modules into medical diagnostics, including the world’s first 5-Megapixel LCD module.
Jason K. Education Details
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Lehigh UniversityEngineering -
Boston UniversityProject Management Certificate
Frequently Asked Questions about Jason K.
What company does Jason K. work for?
Jason K. works for Werfen North America
What is Jason K.'s role at the current company?
Jason K.'s current role is Program Manager at Werfen (Instrumentation Laboratory).
What is Jason K.'s email address?
Jason K.'s email address is jk****@****ssi.com
What is Jason K.'s direct phone number?
Jason K.'s direct phone number is +178189*****
What schools did Jason K. attend?
Jason K. attended Lehigh University, Boston University.
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