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.
• 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.

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.

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.
• 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.

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.

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