Michael Mosholder

Design PMO Manager @ Jabil

About

Engineering manager with extensive experience in a highly competitive contract research and product development environment. • Successfully proposed and managed complex projects with significant electromechanical, biomedical, and software content. • Experienced with System Development Lifecycle on projects ranging in scope from early feasibility through manufacturing transition. • Managed projects ranging from $100K to $15MM with diverse, multi-discipline project teams from 3 up to 25 full-time staff and contractors. • Primary focus on medical device development efforts for drug delivery devices, clinical laboratory instruments, disposable assays for clinical testing, as well as surgical tools. • Extensive experience in complying with the FDA’s Quality System Regulation (QSR) 21 CFR Part 820. Along with extensive project management experience, performed in organizational leadership roles related to business development, staff supervision, and development of project management processes/capabilities.

Country

United States

City

Greater Tampa Bay Area

Industry

Medical Device

Skill

Medical Devices, Product Development, Cross-functional Team Leadership, Product Management, Process Improvement, Project Management, ISO 13485, Design for Manufacturing, Embedded Systems, Continuous Improvement, Design Control, Contract Negotiation, R&D, MS Project, Engineering, Manufacturing, Root Cause Analysis, Project Planning, Biomedical Engineering, Microsoft Project

Experience

Design PMO Manager

Jabil

2017-10 - Present · 9 yrs

St. Petersburg, FL

R&D Engineering Manager

CONMED Corporation

2015-1 - 2017-9 · 2 yrs 9 mos

Largo, FL

Project Manager - NPD

Smith+Nephew

2009-3 - 2015-1 · 5 yrs 11 mos

Vacuum Therapy Devices – Managed project teams in the development, certification, registration and product launch of both new and re-designed vacuum therapy wound pumps • Established user needs and design inputs for device design • Managed mechanical and electrical device design and outsourced software development • Directed development of device Usability Engineering File • Launched three devices certified to the Medical Electrical Safety Standard, IEC 60601-1:2005, including collateral standards for Electromagnetic Disturbances (-1-2 ); Usability(-1-6); Alarms (-1-8) and Home Use (-1-11) in 2013 • Managing team of 12 people plus contractors developing next generation vacuum therapy device • Managed software portal development for Cloud connectivity with next generation wound therapy device. Disposable Dressing Kits – Led project teams in development of a terminally sterilized disposable kits for use with Smith & Nephew vacuum pump technology • Established design inputs and product requirements • implemented biocompatibility and pre-clinical studies to establish product safety • Defined and completed product design verification, validation , product transit and stability testing • Worked with contract manufacturers to establish and implement sterilization validation plans • Launched new abdominal dressing kit product. • Launched three new dressing kits with innovative port technology.

Project/Program Manager

Battelle

1980-1 - 2008-10 · 28 yrs 10 mos

Supervised 10 staff, (performance reviews, training plans, and coaching) Identified and implemented project management process improvements Responsible for Sr. Management oversight on multiple projects Engaged in new business development Established collaborative customer relationships Prepared proposals based on Customer Needs and/or SOW/RFQ Managed diverse, cross-functional teams Communicated with project teams and with management steering committees Detailed project planning, WBS preparation, and cost estimating Performed risk management (identification, prioritization, tracking, triggers, mitigations) Managed and tracked schedules and budgets Applied Earned Value for project status and reporting Managed projects under ISO 9001 and 13485 registered Quality Systems Implemented Design Controls Proficient with MS Office and MS Project