Staff Engineer, Medical Device Risk

Responsible for reviewing risk impact assessments and design change notifications received from R&D and Operations to evaluate potential impact to product safety, effectiveness, and the applicable risk management file. Apply risk management principles across R&D, Operations, and Post-Market Surveillance. Promote existing tools and proper utilization of the risk acceptability criteria. Facilitate cross-functional collaboration sessions with stakeholders from Manufacturing, Quality, R&D, Regulatory Affairs, and other applicable functions to perform and document risk analyses, including PHA, FMEA, and risk impact assessments. Job duties: Evaluate proposed design, process, supplier, and manufacturing changes to determine the impact on product risk and recommend updates to risk management documentation. Review risk impact assessments to determine potential impact to product safety and efficacy including benefit risk analysis. Serve as the technical lead for cross-functional teams in the development, maintenance, and execution of risk management files, including risk assessments, hazard analyses, and FMEAs. Apply established risk management procedures and quality system requirements to risk analysis, risk evaluation, risk control implementation, residual risk assessments, and benefit-risk determinations. Use risk management tools and methodologies, including Preliminary Hazard Analysis (PHA), Failure Modes, and Effects Analysis (FMEA) to identify essential requirements and attributes critical to quality. Facilitate cross-functional risk analysis sessions with Manufacturing, Quality, R&D, Regulatory Affairs, and other applicable stakeholders. Ensure risk management activities, decisions, and supporting documentation are complete, accurate, and compliant with applicable procedures and regulatory requirements. Drive maintenance and continuous improvement of risk management records, ensuring alignment with design changes, manufacturing changes, post-market data, and product lifecycle activities. Provide technical guidance to cross-functional partners on proper use of risk criteria, risk tools, and risk management processes. Support internal audits, regulatory inspections, and quality system activities related to medical device risk management. Identify and recommend opportunities to improve risk management practices, templates, tools, and training to promote consistent application across the organization. Comply with applicable laws, regulations, standards, and Quality Management System requirements, while demonstrating ethics and integrity in all matters. Perform additional duties as assigned.

Minimum of six (6) to eight (8) years of experience in medical device industry operating in Quality Engineering, Product Development, or Manufacturing, including a minimum of one (1) year of experience in project management. Expertise in global regulations pertaining to risk assessment. Experience in the application of applicable risk management regulations and guidance documents, including ISO 14971, 21CFR820, and EU MDR. Proficient at transferring medical device regulatory requirements into practice. Ability to translate regulation requirements into practical procedures. Ability to write and review procedures. Ability to lead complex technical projects. Ability to work effectively and confidently in a team environment. Excellent written and verbal communication skills. Proficient with MS Excel, Word, Project, Outlook, and Teams.