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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

* 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*.

* 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.

Victor, New York, US

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