Tim Roufs Email & Phone Number

Minneapolis, Minnesota, US

Minneapolis, Minnesota, US

• Leading the process development efforts (manufacturing processes, travelers, designing and qualifying fixtures, master validation plans/reports, design trace matrix, PFMEAs, etc.) for a temporary cardiac pacing system.
• Interview and hire new talent for the process development team
• Providing management and career development for Engineers and Technicians including goal setting, work direction, and career development / training opportunities
• Updating quality system documentation to provide more instructions for clarity
• Leading the process development efforts (manufacturing processes, travelers, designing and qualifying fixtures, master validation plans/reports, design trace matrix, PFMEAs, etc.) for lung biopsy systems

Minneapolis, Minnesota, US

• Lead a manufacturing transfer from outside and completed all necessary documentation and testing for a penile traction therapy device.
• Lead and supported a product line from Phase II into Phase IV for an in-office ear tube delivery device.
• Investigated NCMRs root causes and implemented applicable corrective actions to prevent repeat occurrences.

• Sought out and implemented new technology to increase capacity and reduced labor costs.
• Improved testing fixtures, in-process inspections, lead time, and throughput to mitigate costs.
• Completed all necessary testing and documentation required for implementing improvements.
• Executed design changes and material changes necessary for continuous improvements and cost reduction activities.
• Reacted to material changes related to vendor issues and changes to keep producing product without downtime.
• Mentored new engineers in the many facets of being a medical device engineer

Minneapolis, Minnesota, US

• Implemented Lean Objectives on the production lines (5S and Standard Work).
• Improved testing fixtures, in-process inspections, scrap rates, lead time, and throughput to mitigate costs.
• Initiated and implemented work instruction changes that are more understandable for the operators.
• Completed all necessary paperwork like IQs, OQs, and PQs and testing needed for implementing improvements.
• Executed design changes and material changes necessary for continuous improvements and cost reduction activities.
• Reacted to material changes related to vendor issues and changes to keep producing product without downtime.

Marlborough, MA, US

• Developed and tested new processes for new products.
• Improved testing fixtures, in-process inspections, scrap rates, and Ppk/Cpks.
• Initiated and completed Test Method Validations, Gage R&R studies, process improvements, IQ/OQs, DOE testing and analysis.
• Completed all necessary paperwork needed for validation, testing, work instructions, and implementation of improvements.

Marlborough, MA, US

• Developed and tested assembly fixturing to improve processes and products (specifically balloon catheters) on the manufacturing floor.
• Completed all necessary paperwork for implementation of new processes, fixtures, and BOMs.
• Helped train production workers on new procedures and devices.
• Helped with line moves that occurred on the manufacturing floor.

• Designed and developed testing and manufacturing processes and equipment for devices used to correct erectile dysfunction and urinary incontinence.
• Machined and drew prototypes of plastic and aluminum materials.
• Executed lab technician duties including report writing, data analysis, statistical analysis, and material testing.

Bs, Mechanical Engineering

Ba, Physics

Ba, Engineering Science