Greg Causey Email & Phone Number

Broomfield, Co, Us

Brecksville, Ohio, United States

Denver, Colorado, United States

Greater Denver Area

Medical device consulting firm with extensive experience in spine and orthopedics, quality and regulatory, domestic and international.• Product design and development, Class I & II devices, 510(k), FDA Interaction• Product realization process (PDP) development, maintenance, and optimization• Design history file (DHF) implementation, maintenance, audit, and deficiency mitigation• US and International quality and regulatory affairs including, 21 CFR 820, ISO13485, ISO14971

Brecksville, Ohio, United States

Dayton, Ohio Area

Re-focus engineering group in effective and efficient product development. Lead and motivate dynamic team of engineers. Foster and grow department culture through project ownership and empowerment. X-Spine acquired by Bacterin Holdings in July 2015 (two months after start date) resulting in the creation of a new public company, Xtant Medical Holdings.• Oversaw all engineering/R&D in research, development, product launch, and life cycle maintenance. Reported directly to the President and CEO.• Responsible for all QC/RA functions and processes as they relate to product development and maintenance.• Oversaw biomechanical test lab; responsible for all product testing done in support of regulatory filings, marketing/sales support, product evaluation, and quality/complaint analysis.• Worked closely with other department leaders at X-Spine and Bacterin in fostering improved intra-department communications and collaborations. • Collaborated closely with the CSO of Bacterin International in the integration of all R&D activities under the newly created Xtant Medical. Completed all integration activities in less than 6 months.• Worked closely with the VP of Clinical Affairs in the development and implementation of a compliant and efficient surgeon engagement process.

Greater Denver Area

Lead global engineering efforts in the research, development, launch, and maintenance of innovative spinal implant systems. Report to GM and participate on the executive team in determining company direction, project prioritization, staff growth and development, resourcing, and budgeting. Manage all internal manufacturing for prototyping, custom instrumentation, and emergency production. Support sales/marketing in growth through surgeon interaction and engagement, onboarding, training, and surgical support.• Led cross-functional team in R&D in the acquisition and integration of Lanx into the Biomet Spine business unit. Oversaw development of new, global design control system. Drove integration plans for all legacy CAD specifications /design control documentation into an integrated document management system. Interfaced with other integration teams to ensure R&D integration was globally aligned with all integration activities. Completed all integration activates in 9 months.• Managed integration of separate custom instrument manufacturing programs ensuring continued rapid response to field requests was not hampered during the transition period.• Worked closely with sales and marketing leadership to determine product rationalization strategy for the combined product portfolio. Supported surgeon management through transition to updated surgical systems. Planned resourcing for on-going system maintenance to ensure current systems were fully supported through transition.• Responsible for developing and managing budgets for engineering and internal manufacturing departments totaling $15M. • Proactively spearheaded initial international manufacturing efforts to ensure seamless transition of existing Lanx products into the international Biomet supply chain.• Proactively drove integration of separate engineering departments into a single, cohesive team through individual interaction, mentoring, team building, and empowerment.

Greater Denver Area

Guide development of innovative products in a high growth spinal implant company. Grow department resources and capabilities while maintaining a high level of productivity and output. Provide input and participation in overall company direction, strategic growth opportunities, product portfolio prioritization, and resourcing. Manage R&D budgets to meet product launch schedules and timelines. Work closely with other company leaders to ensure adequate resources are available to meet all company goals and expectations.• Integral part of executive leadership team that grew Lanx from 5 employees and $3M in sales to over 200 employees and $80M in sales in 8 years ultimately resulting in acquisition by Biomet. Led the development and launch of over 30 major implant systems. Participated in the creation and expansion of all other company departments through evaluation and strategic hiring: quality, regulatory, purchasing, manufacturing, marketing, operations, and sales.• Worked closely with VP of QC/RA in the development and implementation of company’s QC/RA processes. Developed and implemented a highly efficient and effective NPD process enabling development cycles of 12-18 mo from conception to initial launch. Expanded all development processes to enable the global launch of products into multiple OUS markets. • Managed growth of experienced and capable eng. staff through strategic hires, evaluation, and career/professional growth opportunities. Maximized staff retention through leadership, mentoring, distributed responsibility, and project ownership. Staff turn-over less than 35%.• Developed internal testing capabilities resulting in the first company owned A2LA accredited mechanical test lab in the orthopedics sector. • Drove dept and company culture through empowerment, independence, and expectation of ownership of all projects. Strategic evaluation and hiring of entrepreneurially minded individuals resulted in a “get it done” attitude.

Cleveland/Akron, Ohio Area

• Responsible for development, launch, and support for all company interbody cages: product design, testing, design control documentation, 510(k) writing and FDA communications, system training and OR support. Developed company's first PEEK cervical cage. • Primary author on a State of Ohio Technology Action Fund grant for $750k for next generation "Spinal Implant Development". Funding was used for initial design and kick-off of the Theken eDisc, an experimental electronic artificial disc technology.

Cleveland/Akron, Ohio Area

Center for Automation and Intelligent Systems Research• Designed and constructed a vision-based, high-speed, reconfigurable parts feeding system.• Designed and implemented a distributed, object-oriented controller for a vision-based, high-speed parts feeding system using a variety of programming languages and frameworks.• Oversaw multiple under-graduate and graduate projects.• Performed general system administration tasks on all lab computing resources running a variety of software platforms.• Spearheaded the implementation of secure access to all lab computing resources.

Cleveland/Akron, Ohio Area

• Designed and implemented advanced automation equipment for the high-speed production of battery cells.

Phd, Mechanical Engineering

Center for Automation and Intelligent Systems Research Multidisciplinary, industry funded project examining all aspects of reconfigurable.

Ms, Computer Science

Center for Automation and Intelligent Systems Research Designed, built, and programmed a high-speed, reconfigurable parts feeding system..

Ms, Mechanical Engineering

Tested vibration damping systems for use on alpine ski equipment. Thesis: Testing of Vibration Damping Ski Bindings used on Alpine Ski.

Bs, Mechanical Engineering

High School Diploma