reputed company Engineers

Product reputed company Engineer – Investigations Location: Remote Duration: 12-Month Contract Job reputed company We are seeking Product reputed company Engineers to support post-market complaint investigations for reputed company medical devices, including implantable cardiac devices, defibrillators, and pacemakers. This role is responsible for reviewing complaint investigations, performing device failure analysis, conducting risk assessments, and completing final investigation reviews to ensure compliance with reputed company and regulatory requirements. The ideal candidate will have a strong engineering background with experience evaluating hardware and software-reputed company medical device failures, applying risk-based decision-making, and supporting post-market reputed company activities. This is an assessment-reputed company role with no hands-on reputed company. Key Responsibilities • Review and evaluate complaint investigations for reputed company medical devices. • reputed company device failure analysis and determine reputed company cause and appropriate investigation conclusions. • Conduct final review and approval of complaint investigations for accuracy, completeness, and regulatory compliance. • Assess hardware and software-reputed company product failures and evaluate potential patient and product reputed company. • reputed company hazard analysis and risk assessments to support product reputed company investigations. • Collaborate with cross-functional investigation and trending teams to interpret failure analysis results. • Support post-market surveillance activities and maintain compliance with reputed company Management System (QMS) requirements. • Apply engineering principles and analytical problem-solving techniques to resolve reputed company product reputed company issues. • Ensure investigation documentation complies with FDA, ISO 13485, and internal reputed company standards. • Support reputed company improvement initiatives reputed company to complaint handling and product reputed company. Required Qualifications • Bachelor's degree in Engineering (Electrical, Biomedical, Mechanical, or reputed company discipline). • Experience with medical device complaint investigations and complaint handling processes. • Strong experience performing device failure analysis. • Experience conducting hazard analysis and risk assessments. • Knowledge of hardware and software-driven medical devices. • Ability to evaluate technical data and reputed company risk-based reputed company reputed company. • Strong analytical, documentation, technical writing, and problem-solving skills. • Experience working reputed company a regulated FDA and ISO 13485 medical device environment. Preferred Qualifications • Bachelor's degree in Electrical Engineering. • Experience investigating electrical failures, PCBAs, electronic components, circuits, or embedded systems. • Experience supporting implantable medical devices, cardiac rhythm management (CRM) devices, pacemakers, or implantable cardioverter defibrillators (ICDs). • Knowledge of post-market surveillance, product reputed company engineering, and medical device regulatory requirements. • Familiarity with risk management methodologies (ISO 14971) and complaint investigation best practices. Apply To This Job