Job Details

Job Description:

Responsibilities:

• Lead cross-functional discussions with engineering, design, commercial, and product teams to ensure that all hazards associated with products are identified, risks are estimated, evaluated, controlled, and documented.
• Monitor that risk controls are implemented, verified, and validated for products in development and verify the effectiveness of risk control measures throughout the product life cycle.
• Develop, maintain, and execute risk management plans that support product development and ongoing sustaining activities in accordance with Clients risk management framework.
• Lead periodic reviews of the risk management process and quality system deliverables to ensure ongoing effectiveness and document decisions and actions taken, aligned with Clients quality systems and ensuring compliance with regulatory standards and practices.
• Lead remediation efforts for updating risk management documents and the implementation of the FMEA process.
• Evaluate estimated risk and acceptability for each risk based on analysis outcomes, utilizing Clients risk acceptance criteria. If risks are not acceptable, lead efforts to identify and document risk control methods.
• Support the Benefit-Risk Analysis process and lead the evaluation of overall residual risk, ensuring alignment with Clients strategic objectives.
• Perform and document Risk Reviews to communicate results of the risk management process to cross-functional teams.
• Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk team members.
• Identify opportunities for continuous improvement of the Risk Management Process.
• Facilitate and provide ongoing training on standards/processes as needed to other associates or functions.
• Assist with strategic initiatives and planning.
• Mentor and coach other members on the team and cross-functional teams on risk management processes.

• Familiarity with risk management activities that support client's compliance with various international regulatory bodies, including ISO 14971 and ISO 13485. IEC 60601 and IEC 62304 experience is a plus.
• Experience in the medical device and/or regulated industry (required).
• Experience with remediation efforts and FMEA process implementation with medical devices is a plus.
• Ability to analyze data from clients proprietary sources to calculate risk probabilities and levels effectively.
• Strong communication skills to relay department and area issues, ensuring clarity and cooperation across clients global functional teams.
• Technical experience with Pyxis or automated dispensing cabinets (preferred).

• Bachelor of Science degree in engineering (Mechanical, Electrical, Materials, Biomedical, or related discipline), with a masters degree preferred.
• Quality certifications relevant to client, such as ASQ Certified Quality Engineering, Certified Auditor, and Six Sigma credentials preferred.

• 8+ years in a regulated industry, particularly within the medical device, bio-pharmaceutical, or biotechnology sectors, with a strong preference for experience with medical device or similar organizations.
• 5+ years leading and applying risk management concepts specifically within the context of medical devices ensuring high standards of patient and customer safety.