Christopher Krolak
- Role
- Sr Engineering Manager -software Reliability, Safety, and Supplier Quality at Medtronic
- Location
- Minneapolis, MN, US
- LinkedIn followers
- 500 followers
About Christopher Krolak
At Medtronic, our team excels in delivering software reliability and safety for Cardiac…
Experience
Sr Engineering Manager -software Reliability, Safety, and Supplier Quality
Jul 2021 — Present
Lead a global pre-market software reliability, safety, and supplier quality organization for Cardiac Diagnostic Services (CDS) and Cardiac Rhythm Management (CRM) operating units within Medtronic. My team\'s focus is driving design for reliability in software development and risk mitigation of software changes in an Agile software development environment. Responsibilities and Accomplishments: Responsible for reliability, risk management, and release support for instrumentation, mobile, tablet, and cloud based medical software applications following IEC 62304, ISO 13485, ISO 14971, and 1633 standards. Responsible for supplier quality assurance of software of unknown provenance (SOUP) components developed by 3rd parties. Responsible for scaling a global workforce to support a 20% y/y growth in software development activity. Risk management leadership for new med technology: AI/ML, BL/BLE, cloud, mobile.
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