Sr. Design Quality Engineer

About This Role

Ensure new or modified medical products conform to quality standards and establish compliance with the quality system by serving on product development teams and protecting patient/user safety.

Responsibilities

• Serve on product development teams promoting and assuring quality in product development projects
• Execute and support on-time completion of Design Control Deliverables for projects related to Design Change, Clinical and New Product Development
• Work with cross functional team to execute and/or support various areas of Design Control processes, such as Design Input requirements, Design Outputs, Design Verification and Design Validation
• Support the assessment/establishment of objective, measurable, discrete, and verifiable customer and product requirements
• Support product development equipment qualification activities, inspection method development and validation activities
• Review and approve design, development and verification/validation deliverables in compliance with FDA QSR requirements and ISO standards applicable to implantable medical devices
• Accountable for Applicable Standards Document & checklists, Labeling Verification planning & execution, Essential Output reports, and General Safety and Performance Requirements (GSPR)
• Ensure Design History File content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
• Lead Risk Management activities for development projects and supplier change requests, including generation and maintenance of risk assessments, risk management plan/report, hazard analysis and failure mode effects & criticality analysis (FMECA)
• Maintain Risk Management Deliverables to ensure continued acceptability of products based on post market feedback

Requirements

• 5+ years of quality engineering experience
• Demonstrated use of quality tools/methodologies
• Excellent verbal, written, and interpersonal skills
• Strong analytical/problem solving, critical thinking, and presentation skills
• Advanced computer skills, including statistical/data analysis and report writing skills

Qualifications

• Bachelor’s degree in engineering, technical field OR an equivalent combination of education and work experience
• 5+ years of previous quality engineering experience and demonstrated use of quality tools/methodologies

Nice to Have

• Master’s Degree in Engineering or Technical Field
• Previous Medical Device design and development experience
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EN 45502-1, ISO 14708, EU MDR

Benefits