Risk Engineer

Job Summary

Quantum Surgical is looking for a Risk Engineer to join a team of creative and energetic engineers who are building the next generation of smart tools for minimally invasive therapies.

The Risk Engineer supports the current System Engineering team through developing and maintaining the usability and risk management files of the company’s new products. He/she will bring his/her unique expertise to drive risk management activities with cross-functional teams and ensure the product safety and compliance.

The candidate should have demonstrated experience in a risk management, usability engineering, system engineering or equivalent role for the design of complex systems within a regulated environment. He/she will interface with engineers (System, Software, Robotics, Mechanical, Electrical, Test), Quality/Regulatory as well as Project Management and Clinical teams.

Key Responsibilities

  • Understand clinical performance, product functions and use environment to apply risk management tools & methodologies and drive safety improvements
  • Participate in and lead usability and risk management activities during the whole product development lifecycle, from idea generation to post-market surveillance
  • Work with various engineering teams to provide guidance and direction on risk management and usability engineering
  • Perform risk analysis against features, requirements, architecture, interface and designs through the appropriate application of risk management techniques (hazard analysis, FMEA, etc.)
  • Quantify residual risks and perform risk/benefit analysis
  • Ensure timely creation & update of the products Usability & Risk Management Files
  • Ensure compliance to organizational procedures, regulatory requirements & industry standards
  • Support the Regulatory team to establish the regulatory filings (CE, 510k, etc.)
  • Support the complaint handling/CAPA processes by assisting investigations that evaluate risk

Experiences and Qualifications

  • MS in Engineering (Biomedical, Science, Mechanical) or equivalent
  • 5 years of related experience in risk management or system engineering in the medical device or pharmaceutical industries
  • Knowledge and application of quality systems, design controls and risk management system requirements
  • Knowledge of main applicable regulations and standards (ISO 13485, ISO 14971, IEC 62366, IEC 62304, FDA 21 CFR 820, FDA guidelines)
  • Ability to lead FMEAs (use FMEA, design FMEA, process FMEA)
  • Ability to work across functions and team boundaries
  • Technical expertise in one or more engineering disciplines
  • Solid analytical and problem-solving skills
  • Pragmatic, customer focus approach
  • Excellent communication and documentation skills
  • Highly proficient in oral and written English

Desired Experience

  • Formal risk management training by recognized training institution
  • Experience with products containing software and electromechanical components
  • Knowledge of operating room environment & constraints
  • General understanding of clinical trial processes and requirements