Mark East Email & Phone Number

New Brunswick, Nj, Us

In this role I am the Project Head; encompassing project management and scrum master roles to drive innovative software & hardware MedTech from concept to commercialization.

In this position, I was the Program Leader engaged in close collaboration with R&D, Ortho Care, Regional Commercial, External Operations, and other Ortho functional teams, as well as important external manufacturing business partners, to develop business strategies and ancillary goals and objectives. I also generated and utilized data analysis to identify and analyze Instrument failures to prioritize maintenance functions and Instrument improvements. I was selected as Ortho liaison to lead collaboration with International External Manufacturing partner due to superior cultural adaptability. I also developed PLM for deployment with multiple manufacturing sites. • Improved instrument reliability and out-of-the-box quality by providing program leadership, development, and strategy for the tactical execution of the portfolio of ~150 projects, sub-projects, and tasks.• Participated in Regional Engagement Meetings, Quarterly Business Reviews, and other forums to determine product needs. • Actively took part in QRC Leadership forums and offer direction, coaching, and mentoring to the larger QRC organization. • Performed root cause failure analysis on Instrument failures and develop strategies to prevent recurrence.

Raritan, Nj, Us

In this position, I designed and implemented all processes related to the manufacture of new product/process introduction. I partnered with R&D teams to determine the appropriate manufacturing strategies, systems integration and approach. I also directed design transfer of In-Vitro Diagnostics (IVD) medical devices. In addition, I managed international relationships with Partners in Product Development and External Manufacturers.• Masterminded and directed R&D, Operations, and Service teams to develop compliant ad hoc business processes and deliver design correction to Ortho’s biggest customer in 4 weeks (83% faster), thereby saving account• Defined standardized execution of company-wide Change Impact Assessment in collaboration with all company functions, saving millions each year preventing further field actions.• Launched several next-generation products for standalone use and automation, including the VITROS XT 7600 and VITROS XT 3400, with highest initial quality scores for the business sector.

Raritan, Nj, Us

In this position, I served as the leader of cross-functional and international product development teams to ensure product requirements were met. I ensured risk management plans/reports & FMEAs, systems integration, tech transfer, and manufacturing adhered to medical device regulations. I integrated engineering input to master schedule. I directed business in Ortho’s NPD program and directed front-of-house interaction during regulatory inspections/audits. I also ensured that design improvements were effective, continuous, and compliant.• Improved operational efficiencies by meeting compliance requirements through tool and process design and implementation.• Increased organizational efficiency and reduced the risk of nonconformance by developing Quality Management System (QMS).• Conducted failure analyses and product corrections on existing products. • Developed optimal product performance by using investigation, technical input, six sigma, and lean processes to solve complex problems.

New Brunswick, Nj, Us

In this position, I partnered with manufacturing to implement process improvements and address quality events including non-conformance, product disposition, root cause investigation, and laboratory OOS. I also utilized key Quality Engineering (QE) principles, tools, and practices to develop and optimize process controls and quality system processes that are aligned with the overall business goals and Ortho’s Quality Policy. In addition, I implemented quality management in Material Review Boards (MRB) and over 2,000 nonconformance and CAPA records.• Identified and implemented site-wide lean process improvement in less than 5 months, avoiding recurring costs by $130,000 annually.• Participated in internal and external audits as well as manufacturing investigations.

Free Solutions is scaleable, diverse, and dedicated to providing quality, personable, and reliable Technical and Professional services. Services include Real Estate, Judgment Enforcement, Engineering, and Consulting.

Rochester, Ny, Us

In this position, I managed engineering change activities in support of product and process improvements, identified and implemented cost-cutting measures, and supported the commercialization of new products for both hardware and software products.• Performed a supplier audit with CAPA and realized cost savings of 10% across all machinery cabling through Lean Six Sigma interventions. • Drove suppliers, resources, and processes to realize particular quality initiatives. • Implemented process and technical corrective measures to continuously increase production line efficiency.• Saved $72k in NRE (non-recurring estimate) engineering charges by re-engineering single-line fixtures for multiple product lines.

Purchased high volume business with partner and maintained all financial accounts, ledgers, budgets, as well asdeveloping personnel / public relations. Successfully built efficient leadership team; hiring, training, and managing. Developed and documented all company standards and processes. Created lean and proactive policies. Authored performance reports for various audiences. Managed vendor accounts and constantly optimized sales revenue. Lead day-to-day operations within compliance of authorities. Identified, groomed, and promoted leadership• Revamped business physically and in business recognition within schedule (three months post acquisition) and on-budget with streamlined resources• Sold successful business in within 3 years at 200% return on investment

Aurora, Oh, Us

* Consistently delivered quality consumer products below project budgets while working within company guidelines and interpreting cross functional issues* Worked with company President and Director of R & D to develop multidisciplinary design concepts and see them through to production* Traveled to, and correspond with overseas manufacturing for new product roll-out to US distribution, and for continued product updates* Managed Junior Engineers* Performed failure analysis and initiated corrective actions* Published internal and external documentation for all levels of viewers * Responsible for PCB design and layout incorporating 15 volt logic with 1500 volt switching supply on small PCB real estate* Responsible for prototyping, testing, manufacturing, and documentation for various product lines* Interfaced with distribution representatives for sourcing components* Created, restricted, and reported department purchases sensitive to project and company budgets

* Lead engineer for the design of all electrical circuits, PCB layouts, machine wiring, power management, and documentation of prototype and later machines* Worked hand-in-hand with mechanical engineering team and outside contractors to develop cost efficient, manufacturable subassemblies to coordinate with the electrical engineering design needs* Coordinated with overseas manufacturer to develop and support their first, and sustained, manufacturing processes including incoming inspections and quality control* Brought new electrical design from concept to first prototype in 1/3 of the previous design team’s time, while introducing superior optical gauging* Handled vendor sourcing for in-house design and overseas manufacturing to meet stringent medical specifications* Worked within ISO 9001, EN 46001, and FDA Quality System Regulations* Interviewed prospective test department staff* Sole maintainer of LabView simulation software

* Responsible for the research, development and design of next generation microcontroller-based product and its firmware* Wrote test firmware in C programming language* Completely battery operated design called for operating specifications closely knit in the microampere range* Developed new test fixture and test procedures used in training the test department on new product line* Explored feasibility of new project ventures and published their results

Victor, New York, Us

* Debugged, tested, assembled, and repaired components and accessories of each servo motion control system