Dan Durdin Email & Phone Number

Greater Minneapolis-St. Paul Area

• Performed process development work for new balloon catheter. Made and tested samples. • Use Thulium laser to develop balloon bonding methods.• Updated prototype build process.

Greater Minneapolis-St. Paul Area

• Wrote and performed IQ/OQ/PQ and TMV test protocols and reports for custom manufacturing and test equipment for laparoscopic electrosurgical devices. Wrote Maintenance procedures. • Wrote work instructions for new laparoscopic sealing devices. Released in Windchill.

Greater Minneapolis-St. Paul Area

Write Testing protocols and reports for MRI testing. Write processes for test setup and performing tests. Write and release documentation using Windchill.

Worked on product transfer and remediation of implantable device components, production and packaging equipment, and tooling. Wrote and performed IQ, OQ and PQ protocols and reports. Wrote and updated manufacturing work instructions. Wrote and maintained schedule for my tasks for transfer project. Analyzed product design and made changes to meet production requirements.

Greater Minneapolis-St. Paul Area

Evaluated all design and manufacturing documents and processes for quality for new renal ablation catheter using nitinol. Worked with design engineering to design quality into products. Wrote risk management plan, bio test plan, qualification, and accelerated life test plans and reports. Wrote DFMEA and PFMEA for new product and conducted team reviews to evaluate risk.

Greater Minneapolis-St. Paul Area

Evaluated assemblies and processes for improvements for product validation of a new balloon catheter. Performed DOE’s using Stat-Ease. Wrote PFMEA for new product.

Greater Minneapolis-St. Paul Area

Evaluated and dispositioned non-conforming packaging and products in production. Performed CAPA investigations on packaging. Evaluated processes for improvements

Greater Minneapolis-St. Paul Area

Qualified equipment and validated processes for Atrial Fibrillation catheters assembly, extrusion and molding processes. Wrote equipment qualification protocols and reports (IQ and OQ). Performed QA review of characterization and process validation documents. Utilized Minitab (ANOVA and process capability tools) to determine if processes met requirements. Revised manufacturing processes to improve readability and to reflect revised processes and methods based on validation activities

Greater Minneapolis-St. Paul Area

Analyzed a hand held instrument for cost reductions and quality improvements and implemented solutions to reduce cost. Determined root cause of quality issues on separate device and implemented solutions.

Greater Minneapolis-St. Paul Area

Analyzed prototype handheld instrument design for manufacturability and recommended needed design changes. Wrote project schedule to identify tasks needed to validate and get the unit into production. Sourced vendors to make injection molded parts and assemble the instrument

Greater Minneapolis-St. Paul Area

Wrote OQ and PQ protocols for extruded components utilizing PFMEA data for significance. Performed the process validations, analyzed data using Minitab to determine process capability, and wrote the validation reports. Determined root causes of parts not meeting required capabilities and implemented process changes to enable parts to meet requirements.

Greater Minneapolis-St. Paul Area

• Responsible for all manufacturing related activities to transfer 6 aerosol particle measurement instruments in 3 separate product lines into production. Identified design related manufacturing and quality problems during development phase and worked with design group to implement design changes. Wrote all manufacturing method sheets using Pro-E and digital photos. Validated production processes. Responsible for all SAP work to set up and release parts and BOM’s. Provided manufacturing support to production including line setup and designing fixtures. • Wrote calibration/checkout procedures and data spread sheets for particle testing instruments. Provided work direction to technicians to validate processes.• Set up a mixed model one-piece flow assembly line using standard work processes and point of use inventory. Laid out and set up a prototype manufacturing cell. • Changed layout of main production area to incorporate lean processes and new product line. Managed move of new product line into main production area with no impact on production.

Greater Minneapolis-St. Paul Area

• Responsible for analyzing mechanism in blood testing instrument for manufacturability and made needed design changes to improve quality. Interfaced with outside manufacturing company to resolve startup manufacturing and quality issues. Responsible for getting housing components molded and qualified. Wrote and maintained schedule for the project.• Developed disposable injection molded component to precisely fill a cartridge used with the blood analyzing instruments. Patent Pending. • Developed and validated labeling and packaging for two separate accessory kits.• Analyzed and solved quality and production problems on a blood-analyzing instrument. • Participated in Lean manufacturing/ 6 Sigma team to improve part molding of existing cartridges.

Greater Minneapolis-St. Paul Area

Performed and analyzed DOE’s for medical product assembly and sealing equipment. Employed statistical tools to track process capability and determine root cause of deviations from specification to implement process improvements. Researched and specified high performance coatings.

Greater Minneapolis-St. Paul Area

Introduced a line of electric heaters from 10 kW – 400 kW into air handler line. Wrote project plan, product specifications, schedules, test plans and UL submission documentation. Responsible for system design, validation testing, product documentation and resolving U.L. safety issues.

Greater Minneapolis-St. Paul Area

Senior Manufacturing Engineer - Infusion Systems Division 1997-1999• Responsible for manufacturing activities for bringing a new drug pump into production. Wrote processes and inspection procedures. Designed manufacturing fixtures. Worked with the design group to Identify design and component changes to cut cost and improve reliability. Selected vendors for product components. • Responsible for eliminating latex rubber in all disposable products. Responsible for project plan, team meetings, schedule, validation testing, documentation and FDA regulatory issuesSenior Design Engineer - Access Systems Division 1991-1997• Project leader for two separate projects from concept through production: a winged infusion set, and needle product improvements. Responsible for project plans, design, schedules, FMEA's, test plans and documentation. Facilitated team meetings with other functional groups. Presented project status at monthly management review meetings. Assisted Regulatory department with FDA submissions. • Designed, validated and documented a disposable needle protection device. Patent applied for.• Designed silicone peripherally inserted catheter (PICC) line. Responsible for design, testing, specifications and documentation. Worked with manufacturing to get into production.• Designed, validated and documented a new drug port utilizing custom internal sintered titanium filter.• Developed project management checklist and Microsoft Project schedule template for engineering department to facilitate consistent development of project schedules.• Performed DOE tests to analyze and solve assembly problems with implantable sensor and for molding problems with drug port.

Greater Minneapolis-St. Paul Area

• Project leader and design engineer for deep brain lead system. Designed four conductor lead, positioning hardware and method to attach lead to skull. Wrote and maintained project schedules, facilitated team meetings with other functional groups, wrote qualification test plans, fault tree analysis, and helped write manufacturing procedures and product manual. • Responsible for all electromechanical design and electronic packaging for three separate instruments: TENS unit, muscle stimulator, and arrhythmia monitor. Responsible for plastic case concepts and design, molding issues, battery contact design, electromechanical part selection and testing, documentation, design testing and hazard analysis.• Re-designed TENS unit to decrease manufacturing cost of unit by 15%, while increasing reliability. Worked with manufacturing to set up continuous flow manufacturing line. • Designed and tested new sterile package, including vacuum formed tray design and shipping carton. Validated sealing process and performed ASTM packaging testing.• Redesigned anchor sleeve to double holding force. Utilized QFD to define requirements. • Performed animal study, testing environmental stress cracking effects on urethane tubing.• Redesigned antenna connectors that decreased failure rate from 25% to less than 1%.