John M. Maynard Email & Phone Number

Merrimack, Nh, Us

Chicago, Illinois, Us

Consulting for a Fortune 500 company on a robotic surgical system as a Systems Engineering SME, resulting is a successful 510(k) approval. Interacted with a multi-national PD team on Requirements Traceability Matrixes and DFMEAs (Design Failure Mode and Effects Analysis). Created, reviewed, and compiled IEC 60601-1 and 510K deliverables including risk management, design control, UE and IFU.

Manchester, Nh, Us

As a V&V Manager, co-managing a team of 150+ multi discipline engineers and scientist ensuring the safety and efficacy of medical and non-medical devices through effective and efficient V&V testing. Coordinating multiple teams of Test Managers, Test Engineers and Test Technicians over multiple projects in various stages of development, from concept/feasibility through clinical trials and design transfer. Developing and implementing strategies to improve the engineering process as it involves engineering and formal verification testing, supporting clinical and 510(k) submittals to the FDA. Recruiting and developing V&V staff, fostering skill and career development through mentoring and coaching.

Milford, Ma, Us

Managed direct reports of multi discipline scientist evaluating design changes, improvements and expanded capabilities on released advanced analytical instruments serving multiple markets. As an engineer, provided liaison and coordination between Waters’ R&D engineering teams with system level scientists, assisting in the development and execution of evaluation strategies. Improved the processes used for evaluating and reporting sustaining efforts on multiple platforms.

Minneapolis, Mn, Us

Orchestrated cross functional engineering teams as a player-coach providing Sustaining Engineering and Escalation support of the O-arm 1000.- Selected by Site Leadership to establish a Sustaining Engineering Team. Pioneered a new sustaining process and oversaw a highly efficient and successful team of cross functional engineers supporting:* Reliability Improvements* Failure Analysis* Customer Complaints* Production Threats* EOL Issues* CAPA Projects* RMA Issues* Field Service* Quality Issues- Selected by Site Leadership to create and chair an Escalation Team. Chartered an innovative Escalation Process, addressing internal and external hot issues, that significantly improved solution response time, overall team efficiency and dramatically reduced technical staff interruptions.- Spearheaded O-arm reliability metrics reporting from the User perspective using customer complaint data. Maximized team efficiency and reliability improvements as seen by the customer by identifying highest frequency failure modes and their commonalities. Enhanced reporting led to accelerated root cause identification and effective corrective actions. Improved the O-arm MTBF over 80% within 2.5 years.

Princeton, New Jersey, Us

R&D Manager for the Mechanical and Electrical Engineering departments and Technical Project Leader for key product development efforts, cultivated a disciplined, hands on team environment for technical and non-technical team members. Achieved technology advances and market success with innovative engineering development and strong project management, delivered with the release of the next generation surgical aspirator (CUSA NXT) and multiple devices in the Radiation Therapy and Pain Management market.- Technical Project Leader and hands on technical contributor for the next generation ultrasonic surgical aspirator (CUSA NXT), coordinated a team of up to 20 cross functional members from project inception through full market release, working with medical innovators in the field of ultrasonic surgical aspiration and tissue ablation.- Redesigned the aspiration subsystem improving vacuum levels, enhanced vacuum control, greater pump efficiency and markedly reduced mechanical noise.- R&D Manager for the Mechanical and Electrical R&D Departments. Directed mechanical and electrical engineers ranging from the Principal to the Technician level.- Project Leader for a new pain management device, DiscTrode™: Supervised a team of 12 cross functional members in the development, release and 510(k) approval.- DiscTrode™ was released to Manufacturing on schedule and under budget.- Led new product developments and improvements to legacy products involving: * Electro-Mechanical Systems * Software * Pneumatic Systems * Fluid Handling * Heat Transfer * Precise Mechanical Structures

Designed a medical 4.7mm 3D Video Endoscope, considered at the time the world’s smallest, true rod-lens 3D endoscope in a medical start-up environment.- Created and managed the project schedule from the initial specification and design phases, verification and validation, bio-compatibility and sterilization validations, safety agency testing and clinical evaluations.- Designed and built working prototypes of the 3D Video Endoscope.- Performed cadaver studies with Neurosurgeons. Supported Human Clinical Studies of the 3D Video Endoscope in the U.S. and Europe.

Mba, W/Advanced Certificate In Finance

Bachelor’S Degree, Mechanical Engineering