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 acquisition, processing and analysis of physiologic signals• 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 process.• 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.• Interact with clinical and marketing on the technical assessment and risk management (ISO-14971) of device complaints (CAPA) and feedback.System Integration and Testing • Define and implement system integration and test protocols (mechanical, electrical & embedded software) including design and development of any necessary test fixtures• Define and implement system verification and validation protocols per company guidelines; managed traceability matrix of user needs, requirements through execution of design verification and validation activities and associated documentation that comply with US and international medical device regulations and corporate quality management systems procedures

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 audits.Capital Project Delivery Management• 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 internal manufacturing network.• 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.• Delivered commercial scale, automated, parental drug delivery device assembly, labeling, pack process equipment solutions to internal network and realize business benefits across the biologics product portfolio.• Establish & build strong working relationships with and provide effective oversight of suppliers and manage technical aspects of external collaborations.Research Operations Interface Leadership• Influence and educate cross-functional stakeholders (R&D, Supply-Chain, CMO, QA, Regulatory, Legal, Finance) on device development manufacturability (pFMEA) and commercialization scale-up best practices.• Recruited by business development leadership to serve as device SME during due diligence process; resulted in substantial investment and drug product license & research collaboration agreement .

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 senior management.

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