Oversee multiple validation program teams comprised of SMEs from various technical domains focused on development and execution of validation plans, interpretation, review, and presentation of verification results to business leadership and project teams. Manage new product validation process requiring collaboration with engineering and design teams. Operations leader for global PAE organization with oversight of 7 functional managers and 5 senior leaders.Product Testing – Oversee schedule and technical test results from external partners and internal labs performing environmental, mechanical, reliability, acoustical, and power verification testing for components and full systems.Lead Auditor – Act as Lead Auditor for Bose Medical Device QMS internal and external auditing teams to provide support for FDA inspections.Workflow Process – Designed and introduced a new workflow process for materials team, along with standard operating procedures and instructions to follow that is now utilized by all Bose engineering teams for failure analysis.Product Validation Process – Spearheaded the update of the product validation process with Systems Engineering principles requiring solicitation of key stakeholder needs to support the structure of the business statement of work and engagement models required for contract manufacturers for Consumer Audio and Partnerships products.Product Launches – Validation Program Manager | Team Validation Engineering Lead for new product launches that include: Bose Aviation Headset A30, Bose Ultra Earbuds, Lexi B2 Plus OTC Hearing Aids Powered by Bose.

Managed the program schedule throughout the new product development process for tracking and mitigating risks, validating custom test methods to ensure test lab compliance for medical device verification. Collaborated with European and Asian business partners to execute product performance and compliance requirements.On-site Audit – Conducted on-site audit of European contract manufacturer’s lab to ensure quality & test capabilities.Validation Test – Delivered successful launch of PICVC Military Headset Refresh for Bose Military Division that required multi-day travel to 3rd party test lab for onsite oversight of critical design verification testing.Project Firefly – Led multifunctional technical team of 20+ for improvement of electrostatic discharge standards and testing protocols to set clear system requirements and verification methods for all Bose consumer wearable products.Hearing Aids – Spearheaded launch of SoundControl Hearing Aids for the Bose Health Product Division, as well as the product partnership with HearX Group to launch the Lexi B1 and B2 OTC Hearing Aids, Powered by Bose.FDA Regulation – Successful in delivery of FDA 510K regulatory submission with design verification (DV) testing.Yellow Belt – Led and implemented medically-compliant test sample handoff procedure in time for DV testing.

Managed design verification testing for PDMA and FDA regulatory submissions in the launch of new products.Test Reports – Authored over 36 test reports with key findings and clearly presented results of tests.Protocols – Modeled and drafted complex assemblies that were required for novel protocols and new test lab needs.

Performed research with testing and analysis of the feasibility, design, operation, or performance of equipment, systems, or components within company’s A2LA Certified Calibration Lab.Professional Practice Thesis – Developed Professional Practice Thesis delivering $90K in additional annual revenue.Calibration Procedure – Industry-sponsored thesis led to development of novel calibration procedures that were validated through measurement system analysis. Personally led the training of employees on new procedure. Succeeded in increasing company’s scope to include calibration of Liquid Micro-Flowmeters.

Assisted with power train system demos and testing for customers as part of Winter conditioning.Vehicle Testing – Wrote the requirements for product development and calibration that were evaluated in testing.Maintenance – Established procedures for safety, service schedule, and supply of materials required to efficiently maintain machines or equipment.

Supported Concept Engineering team with creation of bill of materials (BOMs), as well as initial estimates for equipment technology and manufacturing process steps requiring communications with internal technology experts on workflows and manufacturing processes.Technical Reviews – Contributor to onsite customer technical reviews focused on products in acquisition.

Executed verification protocols and testing to support product development projects.Test Automation – Created new test automation program that was incorporated into a new test method.Product Development – Managed coordination of product development PCBAs ensuring safe handling practices.