Senior Design Quality Engineer

Position Summary

The Senior Design Quality Engineer supports Design Controls, risk management activities, and maintains the Design History File (DHF), ensuring compliance with all applicable regulations. This role partners closely with assay development, laboratory operations, regulatory affairs, and quality teams throughout the product lifecycle.

Job Responsibilities

• Create the Design and Development Plan (DDP) for new development projects and update it throughout the lifecycle of the product.
• Create and maintain risk management files with support from cross-functional teams, including risk management plan/report, hazard analysis, dFMEA, uFMEA.
• Provide mentorship, guidance, and training to product development teams new to design controls and risk management processes.
• Review and approve DHF deliverables, including V&V Plan/Protocol/Reports, requirements, and specifications.
• Manage deviations and issues for verification and validation activities.
• Support design reviews and design transfer activities, including process validations, pFMEA, and DMR.
• Support design changes and post-market activities, such as change controls and corrective and preventive actions (CAPA) to ensure product safety.
• Perform risk assessments for regulatory submissions.
• Participate in process improvement initiatives, performing gap analysis and risk communication.
• May work on special projects as needed in regard to Design Controls.

Required Qualifications

• Bachelor’s degree in engineering, scientific or related field.
• Minimum 4+ years of hands-on experience, or relevant comparable background.
• The ability to prepare and understand technical documentation such as technical reports, verification and validation protocols and reports.
• Working knowledge of design controls, risk management and product development processes.
• Experience with ISO 13485, CFR Part 820, ISO 14971.
• Working knowledge of and proficiency in U.S. and International medical device regulations and implementing Quality Systems.

Preferred Qualifications

• ISO 15189, CAP/CLIA and GCP/GCLP preferred.
• Adaptable to fast-paced, dynamic work environment with shifting demands.
• Experience working with eQMS.
• Experience in supporting regulatory inspections.