Nicholas Thayer Email & Phone Number

Raleigh, North Carolina, United States

Morrisville, North Carolina, United States

- Lead drug-device combination product DHF remediation projects for small and large clients- Guide risk management and design control activities from SOP generation to implementation- Manage timelines, communication and project risks

Raleigh-Durham, North Carolina Area

- Developing a novel dental X-Ray device for diagnostic intervention.- Proactively update program strategy in accordance with shifting priorities.- Manage several direct reports including mechanical, electrical and software team leads.- Regularly update stakeholders on project progress, negotiate during resource constraints and mitigate schedule risks.- Manage several overseas vendors for component development.- Remediate quality management system for compliance with design control regulation.- Develop design and risk management plans and train staff on procedures.- Establish project requirements by interpreting regulatory standards.

Norfolk

- Manage project timeline and delegate tasks to direct reports to complete aggressive deliverables.- Create target product profiles and project outlines for pipeline products- Oversee completion of product development and quality activities in support of obtaining FDA clearance.- Setup class 10,000 clean room and arranged manufacturing equipment- Build GMP manufacturing processes and facilitate tech transfer from R&D- Design equipment and experiments to fabricate implantable cell-based soft tissue constructs.

Virginia Beach

• Designed tissue processing equipment for class 3 cardiovascular implants.• Performed validations on laboratory equipment.• Tackled CAPAs using eight disciplines, or 8D, techniques• Developed business case, assembled core team and kicked project off for automating manual clean room process to increase product profit margin by 10% and increase facilities capacity by 25%.• Created production schedules after improving manufacturing process• Used DFM techniques to reduce cost of existing processing equipment by 30%.• Created equipment and tools to be sterilization for aseptic processing in class 100 clean rooms.• Designed biomechanical test fixtures to expedite results and reduce cost.

Newport News, Va

• Designed, fabricated and tested production improvements to optics-based molecular diagnostic device.• Developed microfluidic and vision systems to mix, deliver and measure nanoliter volumes of reagents.• Interfaced with outside vendors to ensure quality specifications are met and project schedule is maintained.• Setup and maintained Solidworks electronic database for revision tracking (PDM).

Newport News, Va

• Maintained consistent up-times on a high-volume manufacturing line by identifying root cause of errors and preventatively reconfigured equipment.• Programmed multi-axis robotic arms with custom end effectors to handle and sense production parts.• Produced drawings using GD&T and precision machining methods.• Developed mechanical and electrical systems of automated cell to handle, assemble and inspect production parts.

Blacksburg

• Contributed to six scholarly publications, four as first author.• Delivered fully actuated humanoid medical patient capable of simulating combative patients, reacting to commands, maintaining eye contact, pupil dilation as well as several medical trauma scenarios.• Interfaced with hospital staff to develop product specifications and give progress updates.• Designed cable-driven robotic hand capable of manipulating objects and typing on a keyboard at 33 words per minute.• Designed experiments and analyzed data on robot systems and electroactive polymer actuator technology.

Blacksburg

• Managed teams of 4+ senior mechanical engineering students to deliver working humanoid robotic systems on schedule and under budget.• Organized meetings and monitored progress to ensure deliverable in 2 semesters.• Taught students the fundamentals of robotics and prepared them for future employment.

Blacksburg

• Supervised undergraduate laboratory experiments• Graded reports and presentations

Salem

• Worked with technicians using Six Sigma techniques to develop efficient layouts for cutting and inspection equipment for manufacturing medical-grade equipment.• Developed dynamic database to transition company files from paper to electronic format using Microsoft Excel.

Blacksburg

• Developed pneumatically actuated serpentine robot for underwater bridge inspection• Traveled to Seoul, South Korea and received top honors at the International Symposium on Education Excellence from over 40 participants for innovation and presentation of our robotic system.

Master Of Business Administration - Mba, Business Administration And Management, General

Master Of Science (M.S.), Mechanical Engineering, Robotics

Bachelor Of Science (B.S.), Mechanical Engineering