Sr. Reliability Engineer - Medical Device

Job ID: 628323

Our client, a leading Medical Device company, is seeking a senior level Reliability Engineer for its growing team. See below for other details!

Top Skills Needed:

• Ability to facilitate discussions and drive consensus of complex topics.
• At least 3 years of experience with ISO 14971 in a medical device company
• At least 3 years of experience creating or maintaining risk management files for medical devices
• At least 3 years of experience working with Quality Design Control deliverables

Can you please confirm the 3 main responsibilities/day to day activities required for this role?

• Updating and Maintaining Risk Management Files for Class III Medical Devices
• Working with project teams to ensure that risk controls are identified and properly implemented, verified, and validated.
• Collaborating with cross-functional teams (including Design, Human Factors, Medical Safety, Reliability and Post-Market Quality) to ensure that all hazards associated with medical devices are identified, the associated risks are estimated, evaluated, and that product/system performance is quantifiably predicted.

Responsibilities:

• In this critical role as Sr. Risk Management Engineer, you will work closely with multidisciplinary project teams to create, and remediate risk management documents that meet ISO 14971 . This role is people oriented, requiring excellent collaboration and communication skills; it also requires persnickety attention to detail.
• Maintain a thorough knowledge and understanding of ISO 14971 and risk management practices, such as Hazard Analysis and Failure Mode and Effects Analysis.
• Collaborate with cross-functional teams (including Design, Human Factors, Medical Safety, Reliability and Post-Market Quality) to ensure that all hazards associated with medical devices are identified, the associated risks are estimated, evaluated, and that product/system performance is quantifiably predicted.
• Work with project teams to ensure that risk controls are identified and properly implemented, verified, and validated
• Evaluate impact of potential issues to patient safety and product performance
• Perform and document Risk Assessments and communicate results to leadership and cross-functional teams.
• Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk Management team members that share in varying pieces of the risk management lifecycle.
• Identify and act upon opportunities for continuous improvement of the Risk Management Process
• Provide input to design/process development, design controls, and design validation for achieving required levels of product safety and performance.
• Create documentation in compliance with applicable procedures to meet project deliverables.

Qualifications:

• Experience with implantable medical devices.
• Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., Product Hazard Analysis, Design and Process FMEA, User Analysis).
• Experience with FDA 21 CFR 820, ISO 13485, European Union (EU) Medical Device Regulation (MDR), and State of the Art (SOTA).
• Experience with Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation, and Design Transfer, and Usability and Human Factor Engineering.
• Experience in the application of statistics.
• Strong attention to detail with the ability to maintain accuracy and thoroughness in all aspects of work.
• Demonstrated leadership skills with confidence in taking initiative and guiding teams effectively.
• Highly proactive and able to anticipate needs, identify opportunities, and act independently to drive results.