Adam Willson, Mba Email & Phone Number

Chaska, Minnesota, United States

Sunnyvale, California, Us

• Established a new procedure for validating test methods used in design verification.• Created a master design history file procedure to enhance traceability and improve audit efficiency.• Developed a new risk management process that incorporates post-market surveillance data into both legacy and ongoing risk management files. Proposed this initiative to management, coordinated a rollout plan including FTE management, and led company-wide training on the new procedure.• Served as the quality representative for the new product development program, specializing in nitinol and stent design.• Achieved Black Belt Certification through Six Sigma Solutions, focusing on the DMAIC process.• Evaluated characterization test data and produced capability assessments based on statistical analysis.• Acted as a subject matter expert in risk management, providing compliance assessments to global standards.• Generated design inputs and created requirement rationales based on internal test data and market trends.• Analyzed advancements in industry technology, including competitive innovations, and applied insights to enhance new product designs.

Abbott Park, Illinois, Us

• Gained understanding for electrophysiology clinical process, terminology and Abbott EP devices.• Collaborated with the marketing and R&D core team to establish validatable user needs and verifiable system/product requirements. • Served as the quality representative on the project team for developing a new capital equipment interface connection.• Assisted in overseeing the transfer of the manufacturing line from Plymouth, MN, to Portland, OR, and Irvine, CA.• Created design verification test plans and protocols, and analyzed and reported test results.• Led risk review board meetings and presented findings to quality management during functional reviews.• Headed the CAPA team to address inaccuracies in the design controls process and identify root causes.• Partnered with a third-party manufacturer to develop an OEM quality plan during the development phase.• Mentored new design quality engineers and interns.

St. Paul, Mn, Us

• Provided technical support to project teams, collaborating with various functional areas, primarily design engineering, on tasks such as preparing test plans, analyzing data, developing and implementing specifications, conducting risk analyses, and implementing design changes.• Led cross-functional teams in completing risk assessment and risk management activities for new and sustaining products.• Developed internal biocompatibility process compliant with ISO 10993-1 and MDR.• Facilitated usability assessments per IEC 62366 and orchestrated physician feedback assessments with successful FDA and PMDA submission for class 2 saline pump.• Translated design requirements into design specifications to ensure device master record is complete• Provided guidance to design engineering, manufacturing and product quality engineering for development of manufacturing test/evaluation methods and process validation.• Reviewed, and approved engineering change orders, design validation plans and reports, test method validations, shelf life plans and reports, equipment qualifications and risk management documents (e.g. Risk Management Plans/Reports, DFMEA, UFMEA and Hazard Analysis).• Initiated CAPAs and participated in CAPA teams. Assisted in root cause analysis for CAPAs.• Ensured clarity and consistency in acceptance criteria and ensured the verification processes capabilities.• Achieved high proficiency in using Minitab for analyzing test and inspection data.• Supported the content of regulatory submissions and ensured compliance with MDD/MDR requirements.• Assist in the creation and maintenance of part assemblies and subassemblies utilizing Solidworks.

St. Paul, Mn, Us

• Investigated and analyzed technical issues related to quality tooling, equipment, and manufacturing processes.• Generated, reviewed and maintained Quality records in support of Quality System, e.g., training, NCMR, CAPA’s, deviation, and Process Validation documents.• Served as the quality representative for new process development and specialized manufacturing projects.• Led process improvement resulting in a 10-day reduction in output times for driveshaft manufacturing.• Reviewed component and sub-assembly drawings for accuracy and dimensional measurability.• Collaborated with a cross-functional team to evaluate the impact of proposed supplier changes.• Developed, revised, and approved PFMEA, validation test protocols, and reports.• Led annual audits and subsequent updates to Master Validation Reports.• Conducted investigations and root cause analyses, driving remediation actions; led a team of three engineers to achieve a 24% annual reduction in sheath scrap.• Provided support during FDA and ISO EN 13485 inspections, both in the backroom and front room.• Provided leadership in the development and use of Tableau business intelligence software to monitor manufacturing data, including scrap, rework, and yield.

St. Paul, Mn, Us

-Designed, manufactured, and used various testing equipment for medical devices-Wrote various methods on how to conduct mechanical testing-Worked 20 hours per week while attending school full time-Trusted with classified technical documents on a day to day basis

Master Of Business Administration - Mba

Bachelor'S Degree, Mechanical Engineering

High School