Overview Selution, in partnership with Cordis, specializes in the development of groundbreaking technology and commercialization of advanced drug-device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. Responsibilities Responsibilities The Principal Sustaining Quality Engineer (Post-Market) will be responsible for ensuring that our medical devices continue to meet the highest standards of quality, safety, and performance after commercialization, helping maintain a state of regulatory compliance and driving process and product improvements. Key Accountabilities • Develop, maintain, and execute post-market plans, procedures, and reporting activities. Ensure post-market processes remain compliant with applicable global regulatory and quality requirements, including FDA regulations, EUMDR, MDSAP, ISO 13485, and other international standards. • Participate in the core team's driving product and process improvements. The post-market team will have responsibility for executing a range of programs from component optimization to developing and implementing next-generation processes. • Risk Management: Maintain and influence Risk Management Files through the management and evaluation of post-market information from complaints, adverse events, product returns, vigilance reports, customer feedback, literature, registries, CAPA, nonconformances, and other relevant sources to assess potential safety impact, severity, reportability, and investigation requirements. • Lead or support complex investigations into product complaints, nonconformities, malfunctions, and field performance issues. Analyze complaint and field-performance data to identify recurring issues, statistically significant trends, and emerging risks. • Establish and maintain post-market metrics, dashboards, trending reports, and management-review inputs. • Support field actions, product recalls, safety notices, product corrections, and customer communications when required. • Participating in internal, supplier, and regulatory audits, including preparation of post-market documentation and responses to audit observations • Maintain awareness of applicable regulations, standards, guidance documents, and industry • Performs other duties as assigned. Key Interactions • Reports to a leadership position. • Potential to interact with all functions, including suppliers and customers, depending on the topic/project being led or supported. Qualifications Required Skills and Experience • Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related field. • 8+ years of progressive experience within the medical device, pharmaceutical, and combination-product industries, with significant experience in Post Market Surveillance (PMS), complaint handling, vigilance, adverse event reporting, and quality systems • Experience with implantable, interventional, catheter-based, drug-device combination, or cardiovascular products [preferred] Competencies & Skills • Working knowledge of applicable requirements and standards, including 21 CFR Part 803 (Medical Device Reporting), EU MDR 2017/745, ISO 13485, ISO 14971, ISO/TR 20416 (Post-Market Surveillance for Medical Devices), and applicable FDA and international complaint handling and vigilance requirements. • Strong technical investigation and problem-solving skills. • Ability to analyze large datasets and recognize meaningful product-performance trends. • Ability to manage multiple investigations and priorities in a regulated environment. • Working knowledge of statistical techniques and trending methodologies. • Strong communication and technical writing skills. • Ability to make independent decisions • Fluent in English Key Success Measures • Timely and technically sound post-market investigations. • Effective identification, interpretation, and escalation of emerging product quality or safety signals. • Accurate and meaningful PMS trending. • Timely completion of PMS and PSUR activities. • Effective linkage between post-market information, risk management, CAPA, and product improvement. • Inspection-ready PMS and supporting documentation. • Strong cross-functional partnership with regulatory, clinical/medical, R&D, manufacturing, and quality. Physical Requirements • Light office work and telecommute capability. • Available to travel 20% of the time, as required for domestic and international • Must be able to lift and carry up to 50 lbs. Competencies & Skills • Working knowledge of applicable requirements and standards, including 21 CFR Part 803 (Medical Device Reporting), EU MDR 2017/745, ISO 13485, ISO 14971, ISO/TR 20416 (Post-Market Surveillance for Medical Devices), and applicable FDA and international complaint handling and vigilance requirements. • Strong technical investigation and problem-solving skills. • Ability to analyze large datasets and recognize meaningful product-performance trends. • Ability to manage multiple investigations and priorities in a regulated environment. • Working knowledge of statistical techniques and trending methodologies. • Strong communication and technical writing skills. • Ability to make independent decisions • Fluent in English Key Success Measures • Timely and technically sound post-market investigations. • Effective identification, interpretation, and escalation of emerging product quality or safety signals. • Accurate and meaningful PMS trending. • Timely completion of PMS and PSUR activities. • Effective linkage between post-market information, risk management, CAPA, and product improvement. • Inspection-ready PMS and supporting documentation. • Strong cross-functional partnership with Regulatory, Clinical/Medical, R&D, manufacturing, and Quality. Physical Requirements • Light office work and telecommute capability. • Available to travel 20% of the time, as required for domestic and international • Must be able to lift and carry up to 50 lbs.