Medtronic is looking to solve the problem of ensuring their software products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business for their cardiac rhythm management products.
Requirements
- Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, ISO 14971, and Hazard Analysis and Risk Analysis techniques (e.g., FTA, DFMEA, Hazard Analysis Logs, Risk Management Report & Files), IEC 62304 / 82304.
- Knowledge of Software Development Live Cycle (SDLC), Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and/or robust design practices.
- Experience in the design, maintenance, or continuation engineering of released software or software systems, including mobile applications.
Responsibilities
- Identify and mitigate patient safety hazards within Medtronic software, working closely with medical safety teams to evaluate device safety from a clinical perspective.
- Ensure risk management files are meticulously developed and maintained in compliance with ISO 13485, ISO 14971, and IEC 62304 standards, while providing critical feedback during the design input and output phases.
- Lead efforts to trace design validation and verification in risk management files, ensuring every safety measure aligns with global standards.
- Recommend innovative risk mitigations and deliver data-driven risk-versus-benefit analyses to project stakeholders, always keeping patient safety as the top priority.
- Collaborates with cross-functional teams to develop and release new cardiac rhythm management software products and design changes.
- Completes risk severity and occurrence determination and analyze risk benefit profiles for cardiac medical products.
- Completes risk analysis studies of new design and processes.
Other
- Bachelor’s degree in Science, Technology, Engineering, Math or a related technical discipline and a minimum of 4 years of technical experience OR a Master's degree with a minimum of 2 years technical experience
- Experience in a highly regulated industry, preferably implantable medical devices
- Advanced degree in Engineering or suitable Clinical/Field Support, Safety or Reliability Engineering, Biomedical Engineering, software development / test, or Product Development Engineering experience
- Strong written and verbal communication skills and ability to work cooperatively and influence outcomes as part of a cross-functional team
- Ability to manage project timelines to execute tasks and deliverables in a timely manner
