Medtronic is looking to solve the problem of ensuring software products exceed safety and reliability requirements and expectations of patients, clinicians, regulators, and the business in the Cardiac Rhythm Management (CRM) Operating Unit.
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
- Bachelor’s degree in Science, Technology, Engineering, Math or a related technical discipline
- Minimum of 4 years of technical experience
- Advanced degree in Engineering or suitable Clinical/Field Support, Safety or Reliability Engineering, Biomedical Engineering, software development / test, or Product Development Engineering experience
- Experience in a highly regulated industry, preferably implantable medical devices
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.
- Plans, leads, and integrates Design for Reliability (DfR) activities on product development projects to drive product safety, complaint reduction, reliability, and quality outcomes that exceed patient, customer, company, and regulatory agency expectations.
- Evaluates designs for potential failure modes, assesses potential hazards and harms, prioritizes safety risks, identifies appropriate risk controls, and compiles evidence to demonstrate benefits outweigh product risks.
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
- 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
- Less than 10% of travel to enhance collaboration and ensure successful completion of projects
- Working on-site 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration
