Brent Henry, M.S. Email & Phone Number

Tysons, VA, US

Pomona, CA, US

• Perform commissioning, qualification, and validation testing on utilities and manufacturing process equipment and instruments
• Author protocols, initiates controlled documentation in support of CQV projects
• Provide project planning, management, execution, and follow up
• QA Remediation (investigate & close Deviation Reports & CAPA's)

Rockville, Maryland, US

• Platform Architecture
• Co-lead the product planning, project management, design, implementation and testing of Class II medical diagnostic EEG devices consisting of complex, integrated hardware and software systems intended for the.
• Develop specifications for device sub-systems and associated data communication, typically including functional requirements, design specifications, and verification/validation procedures adhering to FDA design control.
• Collaborated with internal QA & Regulatory leaders to achieve 8th FDA clearance and MDSAP certification to ISO 13485:2016 standard.Functional Analysis
• Troubleshoot and provide technical assessments of system level performance issues in existing products covering multiple domains (e.g. analog, digital and/or software)
• Contribute to error budgeting, reliability analysis, design for manufacturability, and design for cost programs.

Cambridge, Cambridgeshire, GB

• Design Transfer & Manufacturing Process Validation
• Drafted and executed numerous cGMP traceable design & process control documents: device verification testing, device assembly URS, equipment IQ/OQ/PQ validation & operating SOP’s, & PPQ summary reports.
• Authored cGMP controlled technical reports documenting test results and suggesting engineering and design improvements to enhance process optimization and OEE line performance reliability metrics.
• Co-Developed control strategies (CQA) following risk-based approach for the injection molding and assembly of drug-device components using design controls procedures, participated in supplier quality site.
• Serve as biologics drug delivery device SME and support global engineering functional leadership to successfully deliver capital project objectives and build stronger awareness of the mission within both R&D and global.
• Lead the development of highly capable global manufacturing systems solutions from opportunity evaluation phase to full execution for parental drug-delivery device assembly and pharmaceutical packaging designs.

Chevy Chase, Maryland, US

• Develop system to plan, organize, & control ~$5M facilities major maintenance program.Leverage software tools to schedule tasks, track progress, budget forecasting, and issue detailed performance metrics dashboards to.

Venlo, Limburg, NL

• Led all IVD instrumentation reliability improvement programs, customized quality systems metrics tracking via direct report team, comprehensive issue & resolution tracking via validated JIRA software tool

Rockville, Maryland, US

• Directly managed a high-profile $2M innovative micro-fluidics based instrument development program

Waltham, MA, US

• Acted as lead integration engineer for a DOD agency-sponsored (DTRA) project focusing on producing a dual-scale pathogen sample prep system using immunomagnetic separation.

Venlo, Limburg, NL

• Planned, directed, and coordinated various process automation projects to ensure that goals and objectives were met in accordance with prescribed priorities, timelines, and budget constraints.

Waltham, MA, US

• Co-inventor (US Patent Issued 3/2000) and project leader for engineering development and production of high-throughput oligonucleotide drying apparatus that reduced costs and increased efficiency > 50%.

Master Of Science (Ms), Technology Management

Associate Of Science (A.S.), Mechanical Design

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