Sr. Design Quality Engineer

Roles & Responsibilities

• Serve on product development teams to promote and assure quality in product development projects.
• Execute and support on-time completion of Design Control deliverables for Design Change, Clinical, and New Product Development projects.
• Work with cross-functional teams to execute and support Design Control processes, including Design Inputs, Design Outputs, Design Verification, and Design Validation.
• Support the assessment and establishment of objective, measurable, discrete, and verifiable customer and product requirements.
• Support product development equipment qualification activities and inspection method development and validation activities.
• Review and approve design, development, and verification/validation deliverables in compliance with FDA QSR requirements and applicable ISO standards for implantable medical devices.
• Be accountable for Applicable Standards Documents and checklists, Labeling Verification planning and execution, Essential Output reports, and General Safety and Performance Requirements (GSPR).
• Ensure Design History File (DHF) content completion, integrity, and compliance with regulatory and standards requirements; collaboratively communicate and resolve gaps.
• Lead Risk Management activities for development projects and supplier change requests, including creation and maintenance of risk assessments, risk management plans/reports, hazard analysis, and Failure Mode Effects & Criticality Analysis (FMECA).
• Maintain Risk Management deliverables to ensure continued acceptability of products based on post-market feedback.
• Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Maintain positive and cooperative communication and collaboration with employees, customers, contractors, and vendors at all levels.
• Support company initiatives related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.

• Bachelor's Degree in Engineering, a technical field, or an equivalent combination of education and work experience.
• 5+ years of quality engineering experience with demonstrated use of quality tools and methodologies.
• Excellent verbal, written, and interpersonal communication skills with the ability to communicate effectively at multiple organizational levels.
• Strong analytical, problem-solving, critical thinking, and presentation skills.
• Demonstrated initiative, ownership, and accountability with the ability to plan, prioritize, and meet deadlines.
• Advanced computer skills, including statistical and data analysis and report writing.
• Master's Degree in Engineering or a technical field (preferred).
• Previous medical device design and development experience (preferred).
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EN 45502-1, ISO 14708, EU MDR, and related standards (preferred).