Steve Wehlage

About Steve Wehlage

A broad and experienced Reliability/Quality professional with 30+ years of reliability and quality engineering experience in the medical device and defense system industries. Significant experience in both new product development and market-released product engineering. Very experienced and interested in implantable medical devices such as neurostimulators, leads, drug infusion pumps, catheters, ICDs, pacemakers, and device programmers and rechargers.

Experience

1. Senior Principal Reliability Engineer, Restorative Therapies Group (Rtg)

   Medtronic

   Jul 2017 — Present · Minneapolis, MN, US

   Provide reliability engineering and risk management leadership and support to resolve issues related to market-released products. Participate on cross-functional post-market surveillance teams to review, assess, and resolve customer complaints. Prepare risk assessments to assess patient safety risk of issues and product changes. Manage issue investigations. Drive and participate in corporate and department process improvement initiatives. Provide work guidance and consultation to colleagues and also mentor new employees. Manage department work assignments for 12 employees on a weekly basis in a business unit work tracking system.

Education

• University of Minnesota-Twin Cities

  BS Electrical Engineering

Skills

• Failure Mode and Effects Analysis (Fmea)
• Fmea
• Medical Devices
• Capa
• Design of Experiments
• Cross-Functional Team Leadership
• Iso 14971
• Iso 13485
• Quality System
• V&V
• Quality Control
• Reliability Engineering
• Quality Assurance
• Design Control
• Fda
• Catheters
• Spc
• Corrective and Preventive Action (Capa)
• Statistical Process Control (Spc)
• Dmaic