Senior Software Safety Engineer (Medtech)

TL;DR

Senior Software Safety Engineer (Medtech): Ensuring software products exceed safety and reliability requirements for cardiac rhythm management devices with an accent on risk management and clinical safety. Focus on identifying and mitigating patient safety hazards, maintaining risk management files according to global standards, and conducting data-driven risk-versus-benefit analyses.

Location: Remote (US). Must possess unrestricted U.S. work authorization (Sponsorship not provided for this level).

Salary: $107,200 - $160,800

Company

hirify.global is a global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life through medical innovation.

What you will do

• Identify and mitigate patient safety hazards within software, collaborating with medical safety teams to evaluate clinical risks.
• Develop and maintain risk management files in compliance with ISO 13485, ISO 14971, and IEC 62304 standards.
• Lead efforts to trace design validation and verification in risk management files to align with global safety standards.
• Provide data-driven risk-versus-benefit analyses to stakeholders to prioritize patient safety.
• Analyze risk severity and occurrence for cardiac medical products and conduct risk analysis studies for new designs.
• Develop and execute technical reliability and safety studies, recommending design or test methods to improve product safety.

Requirements

• Bachelor’s degree in STEM with at least 4 years of technical experience OR a Master's degree with 2+ years of experience.
• Unrestricted U.S. work authorization at the time of hire.
• Specific qualification: Medical Doctor with device experience, IBHRE/NASPE certification, or 5+ years of clinical field experience (e.g., Nurse, Clinical Engineer).
• Previous clinical experience related to cardiac therapy products.

Nice to have

• Experience in implantable medical devices or highly regulated industries.
• Knowledge of 21 CFR Part 820, FTA, DFMEA, and Hazard Analysis logs.
• Experience with the Software Development Life Cycle (SDLC), Design for Reliability (DfR), or Design for Six Sigma (DFSS).
• Advanced degree in Engineering or Biomedical Engineering.

Culture & Benefits

• Remote-first work environment with occasional travel (less than 10%) for key meetings.
• Comprehensive health, dental, and vision insurance, including HSA and Flexible Spending Accounts.
• 401(k) plan with employer contribution and match.
• Tuition assistance and reimbursement programs.
• Inclusive culture focused on diversity and global healthcare equity.