Principal 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 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 & 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 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.