David Shirley Email & Phone Number

Saint Paul, Mn, Us

United States

United States

Fridley, Mn

Using INCOSE and ID2MR methodologies to develop leading edge technologies in the neuromodulation space. Working crossfuntionally to ensure robust design and development decisions that drive the future of Medtronic's pelvic health portfolio. Provided systems engineering support for the successful EU and US launches of InterStim Micro System. Currently supporting multiple high priority medical and non-medical software projects set to release soon. Selected to lead covid related software development project with aggressive timeline.

Fridley, Mn

Provided risk management support for Pelvic Health products for the full product life cycle. Modified and lead the ongoing effort to improve the risk management process around change requests for updates to our living files. Developed deep understanding in creation of Hazard Analysis and worked side by side other engineers for the development of DFMEAs. Took additional training outside the scope of standard risk management activities to become a DFMEA coach. Created risk profiles and documentation for clinical research projects that set the foundation for the development of a new process on creating risk management documentation for clinical studies going forward.

Fridley, Mn

Leads continuous improvement activities while driving aggressive goals in on time reporting and compliance. Current responsibilities include: managing non-compliance investigations to obtain root cause and determine corrective actions, managing the creation of responses to regulatory inquires, and providing support to other projects as requested. Historic responsibilities include managing regulatory reporting timeliness, creation of a new internal event coding process and tooling/architecture, managing continuous improvements to coding architecture, supporting A3, DMAIC and CAPA projects.-Exceeded commitments of Complaint timeliness project (90% and 95% of open complaints are less than 60/90 days old), leading to a 130% company wide incentive payout.-Reduced failure rate of critical device malfunction by 50% using DFMEA modalities while supporting the CAPA.-Streamlined the Late MDR/ADR Management Process resulting in 20% decrease in lead time. -Revamped the coding management process by enhancing visibility and decreasing process lead time by 40%.

Stillwater, Mn

Obtained NSCAA level coaching and goalkeeper certifications in first year to lead group and individual training sessions for youth. Specialized in supplying an energetic yet structured learning environment to enhance soccer specific and life skills. Managed two women's traveling teams per year between U12 and U17 while maintaining organized practice schedules, activities and tournament play.

North Saint Paul, Mn

Developed the NSP Polars women's soccer team through instructing practices, organizing squad activities, performing keeper trainings, implementing game strategy and ensuring player development.

Rock Hill, Sc

Worked in the Application Support Center to identify customer specifications, design coating application processes and fixturing, apply applicable PVD coatings to the customers products, and test products to ensure compliance with the customers specifications. Documented all testing methods and results to provide customers with quantitative and qualitative performance specs. Worked with project managers, sales engineers and customers to ensure optimized coating application for their devices. Work performed directly affected the success of the corporation to obtain new business. -Performed root-cause and failure analysis of Physical Vapor Deposition (PVD) processes and process equipment in order to identify and take corrective actions, resulting in approved production specifications-Developed a unique product fixturing concept that increased the batch size by a factor of 8, therefore landing a multi-million dollar account at increased margins.

Agawam, Ma

Started as a manager in training, but position quickly evolved into leading continuous improvement activities as a project engineer. Worked closely with employees to increase production efficiency using 5S and Six Sigma modalities. -Completed two year corporate management-training program in three months. -Supervised a team of technicians tasked with optimizing manufacturing and quality resulting in 20% production efficiency gain using 5S and 6 Sigma tools-Developed damage reducing transportation cases using CAD applications for chip sensitive medical cutting tool, therefore eliminating rejected product by up to 100%.

Supervised eight children with Autism and other disabilities, in a camp setting, for one week every summer. Acted as lead counselor, providing support to all counselors in times of need. Led counselor training sessions to prepare first time counselors with the tools and skills to work with special needs children in a safe and engaging manner.

Provide quality service to customers within a banquet setting.

-Opened the computer lab and monitored student admission. -Assisted students and faculty with computer hardware and software troubleshooting to increase productivity and limit downtime.

Bachelors Of Science, Biomedical Engineering

Bachelors Of Science, Biomedical Engineering

Activities and Societies: AIAA, ASME, Beta Theta Pi (chorister), Men's club soccer (co-coach, treasurer), Women's club soccer (coach).