Engineering Manager - Post Market Risk Management

Full-time - Manager

San Diego, CA

Miscellaneous Manufacturing

About the position

The Engineering Manager - Post Market Risk Management is responsible for overseeing and ensuring compliance with risk management requirements throughout the post-market phase of our medical devices and solutions. This role will lead cross-functional teams during post-market risk management reviews to ensure that all necessary risk management activities are executed in accordance with the quality system. This includes, but is not limited to, risks associated with medical devices such as data integrity, systems security, electricity, moving parts, and usability. The role will lead and coach cross-functional teams on risk management processes that support our commitment to innovation and patient safety.

Responsibilities

• Manage and lead a team of engineers, providing coaching, mentoring, and professional development opportunities focusing on risk management file updates based on post-market data in accordance with ISO 14971.
• Develop, maintain, and execute risk management plans that support ongoing sustaining activities in accordance with our risk management framework.
• Participate in CAPA activities including ownership of CAPA tasks and support field corrective action (FCA) activities.
• Make decisions and recommendations on required actions associated with product issues (e.g. product hold order, health hazard assessment, and field corrective action).
• 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 the post-market phase and verify the effectiveness of risk control measures throughout the product life cycle.
• Lead periodic reviews of the risk management process and quality system deliverables to ensure ongoing effectiveness and document decisions and actions taken, aligned with our 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 our 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 our 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.
• Facilitate and provide ongoing training on standards/processes as needed to other associates or functions.
• Foster a collaborative and inclusive team environment, ensuring effective communication and teamwork.

Requirements

• Familiarity with risk management activities that support compliance with various international regulatory bodies, including ISO 14971 and ISO 13485.
• Experience in the medical device and/or regulated industry (required).
• Experience with post market surveillance and risk management activities.
• Ability to analyze data from proprietary sources to calculate risk probabilities and levels effectively.
• Strong communication skills to relay department and area issues, ensuring clarity and cooperation across global functional teams.
• Technical experience with automated dispensing cabinets (preferred).
• Proven experience in managing and leading teams of engineers, with strong coaching and mentoring skills.

Nice-to-haves

• Master's degree preferred.
• Quality certifications relevant to the industry, such as ASQ Certified Quality Engineering, Certified Auditor, and Six Sigma credentials preferred.

Benefits

• Competitive salary range of $124,100.00 - $204,800.00 USD Annual.
• Opportunities for professional development and career growth.
• A culture that values collaboration and innovation.