Ann Meyer Email & Phone Number

Providence, Rhode Island, United States

Mansfield, Ma

Manage and ensure the quality of the output of the R&D engineering staff, including adherence to customer specifications, integrating quality and regulatory procedures into product specifications, validating the safety and efficacy of the product design through prototype studies and process capability evaluations, and providing technical assistance to Marketing and Manufacturing.• Provided leadership to the R&D group including technical and talent development, creating and managing department budgets, aligning objectives with project goals and assessing the performance of technical staff.• Assisted in the identification of new product opportunities for the DVT Prevention class of trade including product improvements, line extensions, disruptive technologies and market adjacencies through a close working relationship with Marketing.• Led VoC effort on new product development, working closely with outside consultants on subject recruitment, ethnography, interviews, and turning customer needs into product specifications. • Defined resource requirements and negotiated team assignments with project managers and external vendors.• Working in concert with Project Managers, ensured the timely delivery and introduction of new products and product improvements on schedule and on budget. Acted as a project technical lead to bring innovative products to market. • Developed and monitored risk mitigations plans to ensure business and project objectives are met.• Ensured the technical support for the existing base of products. • Provided direction in the resolution of product/project specific technical issues.

Manage and ensure the quality of the output of the R&D engineering staff, including adherence to customer specifications, integrating quality and regulatory procedures into product specifications, validating the safety and efficacy of the product design through prototype studies and process capability evaluations, and providing technical assistance to Marketing and Manufacturing.• Provided leadership to the R&D group including technical and talent development, creating and managing department budgets, aligning objectives with project goals and assessing the performance of technical staff.• Assisted in the identification of new product opportunities for the DVT Prevention class of trade including product improvements, line extensions, disruptive technologies and market adjacencies through a close working relationship with Marketing.• Led VoC effort on new product development, working closely with outside consultants on subject recruitment, ethnography, interviews, and turning customer needs into product specifications. • Defined resource requirements and negotiated team assignments with project managers and external vendors.• Working in concert with Project Managers, ensured the timely delivery and introduction of new products and product improvements on schedule and on budget. Acted as a project technical lead to bring innovative products to market. • Developed and monitored risk mitigations plans to ensure business and project objectives are met.• Ensured the technical support for the existing base of products. • Provided direction in the resolution of product/project specific technical issues.

Served the needs of the business by launching new product codes, integrating an acquisition, providing leverage to the business to support contract negotiations, qualifying new materials/vendors to maintain the existing product line and implementing corrective actions to ensure design quality. Served as Core Team Leader/Technical Lead. Scheduled and managed team members, performed design control, and co-authored 510k and senior management communications.• Applied rigorous analytical methods to analyze and troubleshoot complex design and manufacturing problems. Used tools such as Six Sigma, statistical analysis, SPC, Attribute MSA, and failure mode and effects analysis. • Repeatedly demonstrated ability to quickly transition from team member into project leader on high profile, time-sensitive projects. • Worked closely with Marketing to construct market assessment and financial analysis. Drove effort with Clinical Affairs to locate hospitals and investigators for clinical study to support design validation, 510k submission and a new clinical indication.• Supported filling and prosecution of patent applications. Provided technical support for patent infringement and right to use investigations. Seven patents awarded. • Led and provided technical expertise for vendor driven and customer driven changes to existing product line. Worked closely with Marketing to ensure changes are in alignment with customer expectations, Quality Assurance to ensure changes meets design intent and the Manufacturing site to troubleshoot/support implementation. • Experienced in eliciting customer requirements through voice of the customer interviews.• Coordinated lab equipment/resources to meet the needs of manufacturing transfer projects, sourcing initiatives and quality improvement projects while continuing to support sustaining engineering and new sleeve development projects.• Supervised engineer and technician direct reports. Provided mentoring to junior engineers.

Served the needs of the business by supporting launch of new product codes, integrating an acquisition, qualifying new materials/vendors to maintain the existing product line and implementing corrective actions to ensure design quality.

Served the needs of the business by launching new product codes, providing leverage to the business to support contract negotiations, qualifying new materials/vendors to maintain the existing product line and implementing corrective actions to ensure design quality.

Served the needs of the business by launching new product codes, providing leverage to the business to support contract negotiations, qualifying new materials/vendors to maintain the existing product line and implementing corrective actions to ensure design quality.

Developed disposable biomedical sensors for use in surface electromyographic applications, such as diagnosis of carpal tunnel syndrome and diabetic neuropathy. Applied anthropometric information to determine best sensor geometry. Designed sensors to maximize electronic signal obtained from muscle or muscle groups. • Performed human factors testing on new products to aid in the development of product instructions for use. Created training materials and IFUs for new products to be used in a large scale drug trial.• Coordinated physician training and technical support activities between NEUROMetrix and Fortune 500 pharmaceutical manufacturer. Conducted drug trial specific physician training sessions in Europe and Canada.• Investigated new applications, i.e. new neurological diseases/disorders, for disposable biomedical sensors• Developed and built a system to evaluate the performance of biomedical sensors over time, including circuit board and software design.• Assisted in TUV audits to support obtaining ISO certification. Educated all team members on and enforced design control procedures and regulatory guidelines. Assisted in developing software design control procedures that met new FDA standards.• Coordinated input from various departments to generate product opportunity assessment. Performed risk analysis on all facets of the project, i.e. design issues, marketing message, manufacturing schedule, FMEA

Master Of Science - Ms, Biomedical/Medical Engineering

Bachelor Of Engineering - Be, Biomedical/Medical Engineering