Medical Device Quality Engineer at Blue Ash, OH

About the role

This is a 6-month position in Blue Ash, OH, requiring 7+ years of engineering experience in medical device or other regulated industries. The role involves leading cross-functional technical projects and requires strong expertise in component development, supplier qualification, design verification, and manufacturing validation.

Responsibilities

• Lead multiple high-priority lifecycle change projects from concept through implementation.
• Drive project plans, timelines, risk mitigation strategies, and implementation readiness.
• Coordinate cross-functional teams across Engineering, Quality, Regulatory, Manufacturing, Supply Chain, Procurement, Operations, and external suppliers.
• Serve as the technical interface with suppliers for component development, DFM reviews, tooling readiness, process capability, and component qualification.
• Support design verification and validation activities, including test planning, execution, data review, and technical documentation.
• Partner with manufacturing sites on process validation activities, including IQ/OQ/PQ, pilot builds, validation builds, and production launch readiness.
• Apply strong knowledge of design controls, engineering change management, risk management, quality system requirements, and regulatory expectations.
• Review engineering drawings, specifications, GD&T requirements, tolerance analyses, and component acceptance criteria.
• Drive root cause analysis, technical problem solving, and timely closure of project issues.
• Communicate project status, risks, decisions, and recommendations clearly to stakeholders and senior leadership.
• Demonstrate strong ownership, urgency, accountability, and ability to influence without direct authority.

Required Technical Skills

• Strong expertise in Medical Device Product Lifecycle Management (PLM), Design Controls, and Engineering Change Management (ECO/ECN/ECR).
• Hands-on experience with Design Verification & Validation (V&V), test methods, protocol development, and technical documentation.
• Deep understanding of Risk Management methodologies, including ISO 14971, DFMEA, PFMEA, and hazard analysis.
• Knowledge of Quality Management Systems (QMS), ISO 13485, FDA 21 CFR Part 820/QMSR, and regulatory compliance requirements.
• Experience in Supplier Quality Engineering, component qualification, supplier development, and Design for Manufacturability (DFM).
• Proficiency in Process Validation activities including IQ/OQ/PQ, pilot builds, validation builds, and manufacturing transfer.
• Ability to interpret engineering drawings, GD&T, tolerance stack-ups, specifications, and acceptance criteria.
• Strong root cause analysis and problem-solving skills utilizing 8D, CAPA, 5 Why, Fishbone, and corrective action processes.
• Excellent project management skills, including planning, scheduling, risk management, stakeholder management, and cross-functional coordination.
• Effective leadership, communication, and influencing skills, with the ability to drive decisions and deliver results without direct authority.

Qualifications

• 7+ years of engineering experience in medical device or other regulated industries.
• Experience leading cross-functional technical projects.
• Experience with component development, supplier qualification, design verification, and manufacturing validation.
• Strong understanding of design controls, change management, risk management, process validation, and quality system compliance.
• Strong communication skills, with proficiency in reading, writing, and speaking English.
• Ability to multitask, understand customer requirements, and respond promptly and accurately.
• Capability to prioritize and manage multiple tasks in a fast paced environment.
• Ability to understand and follow complex written procedures.
• Ability to work effectively in a team environment and contribute to team goals.
• Strong decision making and problem solving abilities with sound situational judgment.