Risk Management Engineer, Quality - Defined Term

Job Overview

The primary purpose of this position is to establish, maintain, and continuously improve product and process risk management activities throughout the medical device lifecycle. The Risk Management Engineer serves as the subject matter expert for ISO 14971 risk management processes and is responsible for development and maintenance of Risk Management Files (RMFs), hazard analyses, risk assessments, and risk-related documentation to ensure compliance with applicable regulatory requirements and company procedures. This role partners closely with Engineering, Sustaining Engineering, Quality, Regulatory Affairs, Operations, Clinical Affairs, and Supply Chain functions to ensure product risks are appropriately identified, evaluated, controlled, and monitored throughout the product lifecycle.

This is a “Defined Term” assignment that will last approximately 12 months or until project is complete.  Defined Term employees are eligible for most benefits (including health insurance and paid time off) while on assignment.

Job Responsibilities and Essential Duties:

• Perform all activities in compliance with the Quality Management System (QMS), FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR 2017/745, and other applicable regulatory requirements.
• Establish, maintain, remediate, and continuously improve Risk Management Files for medical devices throughout product development and commercialization.
• Lead product risk assessments including Hazard Analysis, Design FMEA (dFMEA), Process FMEA (pFMEA), Use-Related Risk Analysis, and post-market risk evaluations.
• Facilitate cross-functional risk management activities with Engineering, Sustaining Engineering, Quality, Regulatory Affairs, Operations, Clinical Affairs, and Supply Chain .
• Identify hazards, foreseeable misuse, hazardous situations, and potential harms associated with medical devices.
• Evaluate risk acceptability and ensure implementation of appropriate risk control measures.
• Verify and document effectiveness of risk control measures and residual risk acceptability.
• Ensure traceability between identified hazards, risk controls, design requirements, verification activities, complaints, CAPAs, and post-market surveillance data.
• May participate in complaint investigations, nonconformance investigations, CAPAs, supplier quality issues, and root cause analysis activities to assess product risk impacts.
• Monitor post-market surveillance data including complaints, customer feedback, nonconformities, service reports, and adverse events to identify emerging risks.
• Support internal, external, FDA, Notified Body, and corporate audits related to risk management documentation and processes.
• Develop and deliver risk management training to employees across the organization.
• Support the development and maintenance of risk management procedures, work instructions, and templates.
• Assist management with ongoing quality improvement initiatives and risk-based decision-making activities.
• May be required to perform other duties as assigned or as needed.

Required Knowledge, Skills and Abilities:

• Proficiency in technical documentation and oral and written communication skills
• Knowledge of medical device regulatory requirements, including FDA 21CFR 820, ISO 9001:2015, ISO 13485:2016, etc. Medical device experience highly preferred.
• Strong knowledge of ISO 14971 medical device risk management principles and methodologies.
• Experience facilitating and documenting DFMEA, PFMEA, UFMEA, Hazard Analysis, Fault Tree Analysis (FTA), and risk-benefit assessments.
• Strong knowledge in regulatory requirements for the medical device industry, particularly working experience in design control.
• Capable of effectively interfacing with cross-functional team members in achieving common goals.
• Attention to detail and high level of accuracy.
• Good organizational skills and the ability to handle multiple projects at once.
• Proficiency with Microsoft Office applications and electronic quality management systems (eQMS).

Minimum Requirements:

• Requires a Bachelor's degree in Engineering, Biomedical Engineering, Quality, Life Sciences, or a related technical discipline with 5+ years of experience in medical device manufacturing, product development, quality engineering, or risk management.

OR

• Requires a Master's degree in Engineering, Biomedical Engineering, Quality, Life Sciences, or a related technical discipline with 3+ years of experience in medical device manufacturing, product development, quality engineering, or risk management.

Quality Requirements:

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend all required Quality & Compliance training at the specified interval.
• Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions:

• Standing and or sitting for long periods of time.

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.