Senior Medical Device Quality Engineer

Role Overview:

This Senior Engineer role is critical for leading high-priority lifecycle change projects within the medical device or other regulated industries. The position involves driving project plans, ensuring compliance with stringent design controls, risk management, and quality systems, while coordinating diverse cross-functional teams and external suppliers from concept through implementation.

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, with the ability to drive decisions and deliver results without direct authority.
• 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.

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.
• Senior Engineer level.

Preferred Skills:

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