Kevin Ekins

Design

• Identified problems and specific resolutions to improve manufacturing processes
• Developed solid models via SolidWorks
• Performed 3-D printing prototyping
• Created technical drawings utilizing GD&T standards
• Conducted tolerance stack analysis
• Conducted end-user testing and feedback
• Developed validation strategies and protocols

Risk Analysis

• Generated and revised PFMEAs
• Took part in Corrective and Preventative Action investigation and implementation
• Performed root cause analysis on nonconformance events

Technical Writing

• Wrote work instruction documentation relating to manufacturing line maintenance and operation
• Wrote technical reviews, studies and validation reports
• Created presentations for cross functional teams
• Designed and conducted MSAs on novel measurement systems

Manufacturing line support

• Assisted with day-to-day operations, working efficiently and productively with all team members
• Served as technical liaison between multiple departments and teams to resolve technical and quality issues

Quality Nonconformance Investigations

• Performed quality inspections and drafted reports to detail non-conforming material issues
• Assessed impact to product
• Defined the scope of affected product
• Contributed to root cause analysis to determine core reason for failures and errors
• Determined the actions taken to correct nonconformance

Product Control Plan Revision

• Determined adequate sampling size
• Designed and implemented quality control processes

Biosaftey Laboratory Work

• Grew organisms via plate and liquid media (including blood culture)
• Grew organisms while maintaining antimicrobial phenotypes
• Performed organism enumeration - digital PCR, serial dilution, spiral plate
• Processed patient samples (blood, sputum, synovial fluid)

Validation Studies

• Gathered, arranged, and corrected research data to create representative graphs and charts highlighting results for presentations
• Validated incoming data to check information accuracy and integrity while independently locating and correcting concerns
• Helped team meet regulatory requirements by coordinating documentation and filings.
• Conducted Exclusivity/Inclusivity studies of organisms related to patient sample
  type
• Established the limit of detection of molecular diagnostic tests
• Conducted repeatability and reproducibility studies of molecular diagnostic tests
• Determined interfering/inhibitory substances of PCR based tests
• Wrote reports describing study outcomes for FDA submission