Design Quality Engineer

Job Title: Component Lifecycle / Design Quality Engineer

Location: Blue Ash, Ohio
Work Arrangement: Onsite

Duration : Long Term Contract




Job Summary

We are looking for an experienced Component Lifecycle / Design Quality Engineer to lead high-priority component lifecycle and technical projects from concept through implementation. The ideal candidate will have strong experience in medical device product lifecycle management, design controls, engineering change management, supplier qualification, design verification and validation, process validation, and risk management.

This role requires strong cross-functional leadership and the ability to work closely with Engineering, Quality, Regulatory, Manufacturing, Supply Chain, Procurement, Operations, and external suppliers.

Must-Have Technical / Functional 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), including test methods, protocol development, execution, and technical documentation.
• Deep understanding of Risk Management, including ISO 14971, DFMEA, PFMEA, and hazard analysis.
• Knowledge of Quality Management Systems (QMS), including ISO 13485, FDA 21 CFR Part 820/QSR, and related regulatory requirements.
• Experience in Supplier Quality Engineering, component qualification, supplier development, and Design for Manufacturability (DFM).
• Experience with Process Validation, 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 using 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.

Roles & Responsibilities

• Lead multiple high-priority component lifecycle change projects from concept through implementation.
• Develop and 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
  • 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, process validation, quality system requirements, and regulatory expectations.
• Review engineering drawings, specifications, GD&T requirements, tolerance analyses, and component acceptance criteria.
• Demonstrate strong ownership, urgency, accountability, and the ability to influence stakeholders without direct authority.

General Managerial / Professional Skills

• Strong communication skills with proficiency in reading, writing, and speaking English.
• Ability to multitask, understand customer requirements, and respond promptly and accurately.
• Ability 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.

Ideal Candidate Profile

The strongest candidates will have:

• 1+ years of engineering experience in Medical Device or another highly regulated industry.
• Experience leading cross-functional technical projects.
• Strong background in component development, supplier qualification, design verification, and manufacturing validation.
• Hands-on knowledge of PLM, Design Controls, V&V, Risk Management, QMS, and regulatory compliance.
• Experience working with suppliers and manufacturing teams throughout the component/product lifecycle.
• Strong communication, leadership, problem-solving, and stakeholder-influencing skills.