Senior Medical Device Quality Engineer

Role Overview:

This Senior Medical Device Quality Engineer role involves leading multiple high-priority lifecycle change projects from concept through implementation within the medical device or other regulated industries. The position requires strong expertise in design controls, risk management, quality management systems, and process validation to ensure regulatory compliance and product quality.

Key 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 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.
• EIS : MDD Risk Management.

Qualifications:

• 6-8 years of experience required.
• 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.

Preferred Skills:

• EIS : New Product Development (NPD) Methodology and Management.