Our client, a leading global consumer-centric medical device company is seeking a Risk Management Engineer.
Type: Direct Hire
Responsibilities:
- Creating and maintaining product risk management files that are aligned with applicable standards (e.g., ISO 14971) and regulations (e.g., 21 CFR Part 820 and EU-MDR/EU-IVDR)
- Leading product risk management teams through periodic and event-driven risk assessments and risk management reviews
- Leading risk assessments associated with reported issues involving clinically available product
- Assessing trends in production or post-production data that could signal a safety- or performance-related issue
- Leading or actively participating in the investigation of complex product- or process-related issues
- Leading or actively participating in CAPA investigations or CAPA actions related to medical device risk management, product safety, implementation of risk control measures, or assessment of effectiveness related to risk control measures
- Actively representing the Risk Management function on cross-functional teams
- Promoting continuous improvement of products and process
- Mentoring individuals in other functional areas on Risk Management methodologies as needed
- Providing guidance to ensure that design control requirements are being met in an effective manner, including those for design/specification development, design verification, design validation, process development, process validation, and design review
- Providing input regarding design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested
- Creating, evaluating, and validating product-related test methods
- Evaluating test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives
- Complying with applicable medical device and business practice regulations
- Representing company as needed before FDA inspectors or internal/external auditor
Qualifications:
- Bachelor of Science degree (or an equivalent amount of technical training and experience) in an Engineering or Science field
- Minimum of 1 year preferred as a scientist / engineer in the medical device or pharmaceutical industry
- Prior experience in a role involving medical device or pharmaceutical risk management preferred
- Prior experience in a role involving root-cause investigation preferred
- Prior experience with post-market surveillance preferred