ResponsibilitiesResponsibilitiesThe 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.
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]
QualificationsRequired 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.
Preferred QualificationsPay / CompensationThe expected pre-tax pay rate for this position is $114,950 - 165,000 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
