Robert Kissee Email & Phone Number

United States

Rancho Santa Margarita, California, United States

- Designed new medical device packaging sterile barrier system ensuring ISO 11607 compliance- Collaborated with three engineers to qualify and implement a packaging material change across an entire product family (15 devices), resulting in annual cost savings of $200,000- Performed product packaging design cost analysis and initiated project to save $100,000 annually- Developed a master validation plan and operational qualification (OQ) protocol to adjust manufacturing in-process inspections across 10+ devices due to packaging material seal strength variance- Trained Quality Engineer to optimize package sealing equipment parameters (pressure/temperature/time) using design of experiments (DOE) and increased package strength by 43% and process efficiency by 25%- Documented packaging non-conformances and complaints, conducted root cause analysis (RCA), and presented findings to senior management, averting product recalls on three occasions- Validated automated vision systems and increased product packaging inspection output by 29%- Designed and updated fixture CAD models and drawings for use in product testing and manufacturing- Mentoring Engineer I direct report in Medical Device Packaging

Rancho Santa Margarita, California, United States

- Executed validation plan with IQ, OQ, PQ for $500,000 Form Fill and Seal (FFS) packaging equipment and tooling, boosting medical device packaging output by 50%- Performed quarterly risk management analysis for packaging complaints to maintain ISO 9001 compliance- Supported production maintenance in troubleshooting equipment to restore production activities- Developed and maintained SOPs, manufacturing instructions, pFMEAs, Control Plans, and SolidWorks engineering drawings for parts, raw materials, and finished goods- Led Non-Conformance Investigations to find the root cause and restore production shop orders- Worked with procurement to qualify suppliers and supplier materials- Mentored Engineering Intern to design medical packaging machine material cover to prevent particulate matter

Irvine, California, United States

- Resolved packaging challenges for industrial design team through SolidWorks FEA Simulation- Conducted time studies and delivered competitor analysis presentations to Senior Product Management- Collected and organized data using Excel to establish product key performance indicators

Bachelor Of Science - Bs, Mechanical Engineering, 3.75 Gpa

Associate'S Degree, 3.95 Gpa