Thomas Danowski Jr Email & Phone Number

Hanover, Maryland , Us

Responsible for overseeing multiple center-based and onsite managed Mechanical and Electrical Product Design & Engineering projects related to medical device industry.Ensure compliance to customer standards, quality standards, regulatory requirements, etc.Develop and manage project plans, budgets, schedules, and documentation including change management, risk mitigation, and metrics reporting.Manage development, implementation, and evaluation of complex designs.Oversee product construction and testing in order to ensure completion of projects as efficiently and effectively as possible.Align project management with account management.Distribute workflow from customer to Project Leader and their teams. Plans and directs all design engineers, designers, and technical engineers working on specific projects.Maintain a high-level of relationships with all customer stakeholders.Utilize program management skills of communication, presentation, time management, organization and planning to successfully achieve program goals, objectives, and SLAs.Conduct status meeting with customers and team to access progress against plan.Prepare and deliver weekly/monthly status reports to management and appropriate client recipients.Takes initiatives in Continuous Improvement and CAPA processes.Support business development in pursuit of opportunites.

Ann Arbor, Michigan, Us

Attract, develop, engage, train and retain talented personnel; create a work environment where personnel can realize their full potential, thus allowing the organization to meet business needs.Project Technical Leader/Subject Matter Expert on large product development projects with multi-disciplinary teams to deliver design changes and new products to market.Conduct Formative and Summative Usability Plans, Protocols, and Reports per IEC 62366.Apply engineering knowledge to the design and development of new products as well as product changes and enhancements (510k).Utilize engineering skills to solve engineering problems at the component through system level. Conduct testing utilizing existing test protocols or develop new ones as needed.Work with other functional areas within the company to coordinate introduction of new products and improvements of existing products/processes.Contribute to the intellectual property position of the company via invention and patent applications and documentation in technical notebooks.Develop and maintain knowledge of medical device industry, including understanding of current technologies and trends, through actions such as professional memberships, attendance at conferences and/or seminars, subscription to trade magazines, etc.Provide strategic direction to the monitoring platform.Plan, implement, lead and execute project tasks according to project plan.Provide engineering expertise in the hardware/software design and development, design verification, design validation. Includes UL testing, design change control, risk management, DMR, and DHF creation and update.

Ann Arbor, Michigan, Us

Perform Design Verification and Validation on Product Updates (510k Clearance). Conduct Formative and Summative Usability Plans, Protocols, and Reports per IEC 62366.Teach and Mentor Engineers.Customer Interaction to Understand Customer Needs in Order to Incorporate Needs Into Next Round of Product Updates.Initiate/Conduct Health Hazard Investigations (HHI) And Present to Cross-Functional Management.Lead Corrective Action/Preventative Action (CAPA) Activities for Product.Lead and Support Company Audits as the Subject Matter Expert.Lead and Support All Technical Leaders on Engineering Projects.Continuous Improvement of Product and Procedures Used By Department. Includes Designing “Future-State” With Cross-Functional Team By Utilizing FDA Regulations And ISO Requirements.

Ann Arbor, Michigan, Us

Maintain Design History File for Product. Teach and Mentor Engineers.Perform Design Verification and Validation on Product Updates (510k Clearance). Customer Interaction to Understand Customer Needs in Order to Incorporate Needs Into Next Round of Product Updates.Initiate/Conduct Health Hazard Investigations (HHI) And Present to Cross-Functional Management. Lead Corrective Action/Preventative Action (CAPA) Activities for Product.Lead and Support Company Audits as the Subject Matter Expert.Lead and Support All Technical Leaders on Engineering Projects. Continuous Improvement of Product and Procedures Used By Department. Includes Designing “Future-State” With Cross-Functional Team By Utilizing FDA Regulations And ISO Requirements.

Ann Arbor, Michigan, Us

Maintain Design History File for Product. Teach and Mentor Engineers.Perform Design Verification and Validation on Product Updates (510k Clearance). Customer Interaction to Understand Customer Needs in Order to Incorporate Needs Into Next Round of Product Updates.Initiate/Conduct Health Hazard Investigations (HHI) And Present to Cross-Functional Management. Lead Corrective Action/Preventative Action (CAPA) Activities for Product.Lead and Support Company Audits as the Subject Matter Expert.Lead and Support All Technical Leaders on Engineering Projects. Continuous Improvement of Product and Procedures Used By Department. Includes Designing “Future-State” With Cross-Functional Team By Utilizing FDA Regulations And ISO Requirements.

Ann Arbor, Michigan, Us

Conduct Failure Analysis Utilizing Multiple Recognized Test Methodologies. Initiate/Support Corrective Action/Preventative Action (CAPA) Activities.Team Leader For Complaints Reduction Project. Goal To Reduce Open Complaints Greater Than 90 Days To 15% Of Total Open By July 27, 2012. Project Completed 22 Days Early. Continuous Improvement Of Processes and Procedures Used By Department. Includes Designing “Future-State” With Cross-Functional Team By Utilizing FDA Regulations And ISO Requirements.

Masters Of Science In Engineering Management, Engineering/Industrial Management

Bachelors Of Science Engineering, Mechanical Engineering