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 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, andregulatoryaudits, includingpreparationofpost-market documentationandresponsestoaudit observations Maintain awarenessofapplicableregulations, standards, guidancedocuments, andindustry 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.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 & SkillsWorking 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 decisionsFluent in EnglishKey Success MeasuresTimely 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 for domestic and internationalMust be able to lift and carry up to 50 lbs. Competencies & SkillsWorking 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 decisionsFluent in EnglishKey Success MeasuresTimely 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 internationalMust be able to lift and carry up to 50 lbs.
