Pre-Market Software Reliability Engineering Manager - CRM
Core
Lead software reliability engineering for R&D projects to ensure medical device products meet safety and reliability requirements for patients, clinicians, and regulators.
Role type
Pre-market Software Reliability Engineering Manager
Builds
Embedded software systems for cardiac and vascular medical devices
Domain
Medical devices / Cardiac Rhythm Management
Deliverable
production ML models | product features | infrastructure
Required skills
Team management, budget management, resource allocation, performance coaching, cross-functional collaboration, risk review leadership, QMS deliverable review
Preferred skills
Certified Reliability Engineer (CRE), Certified Software Quality Engineer (CSQE), software fault tolerant design, FMEA/FTA, reliability growth models, DevOps, Agile, IEC 62304, ISO 13485, ISO 14971, Design for Six Sigma
Technologies
Spreadsheets, project management tools
Responsibilities
Manage direct and dotted-line reports, build and maintain high-performing teams, recruit and onboard staff, define organizational initiatives, plan R&D project budgets, review QMS deliverables
Seniority
Manager, hands-on leadership