Senior Sustaining Quality Engineer (Post Market)

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 The Senior 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 the Risk Management Files through management and evaluation of post-market information from complaints, adverse events, product returns, vigilance reports, customer feedback, literature, registries, CAPA, NC and other relevant sources to determine potential safety impact, severity, reportability, and investigation requirements. Conduct or support 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. 5+ 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), 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 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 domestic and international Must be able to lift and carry up to 50 lbs. Pay / Compensation The expected pre-tax pay rate for this position is $97,900 – 130,900 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

The Senior 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 the Risk Management Files through management and evaluation of post-market information from complaints, adverse events, product returns, vigilance reports, customer feedback, literature, registries, CAPA, NC and other relevant sources to determine potential safety impact, severity, reportability, and investigation requirements. Conduct or support 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.

Required Skills and Experience Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related field. 5+ 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), 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 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 domestic and international Must be able to lift and carry up to 50 lbs. Pay / Compensation The expected pre-tax pay rate for this position is $97,900 – 130,900 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.