Design Quality Engineer I

Johnson & Johnson Innovative Medicine•West Chester, PA

About The Position

The Design Quality Engineer I supports the Design Quality Engineering Group under DePuy Synthes for the Trauma, Extremities, Craniomaxillofacial (CMF), and Animal Health businesses. The role helps launch and sustain orthopaedic implants and associated instrumentation, contributing to product development, innovation, and lifecycle support by applying technical knowledge to ensure product performance, safety, and regulatory compliance. It collaborates across R&D, Quality, Regulatory, and Manufacturing teams to support solutions intended to improve patient outcomes.

Requirements

Bachelor of Science degree in Engineering and/or a Technical Science.
At least 1 year of experience in a GMP- and/or ISO-regulated industry; internships, co-ops, and practical experience count.
Proficiency with the Microsoft Office Suite.
Fluent English.

Nice To Haves

New product development experience or prior experience in a medical device or healthcare field.
Working knowledge of QSR (21 CFR 820) and ISO 13485 and ISO 14971 quality requirements.
Blueprint literacy, including GD&T.
Knowledge of process and design excellence tools; certification is a plus.
Excellent problem-solving, decision-making, and root cause analysis skills.
Interpersonal skills that foster conflict resolution in technical situations.
Ability to embrace collaboration, change, risk-based decision-making, and flexibility.
Self-motivation and willingness to take action.
Excellent written and verbal communication skills.

Responsibilities

Support product development and lifecycle management activities related to the Trauma and CMF businesses.
Lead product realization planning for new projects and previously launched products, including conducting formal technical design reviews throughout product realization.
Support design verification and validation activities, including mechanical testing, tolerance analyses, design rationales, and surgeon-based anatomical labs.
Apply statistical methods and design excellence tools to design verification and validation activities.
Support risk management activities, including planning, design and clinical risk management, production risk management, and overall risk-benefit reporting.
Work with suppliers to qualify new parts and processes and support transfers to manufacturing for product development and base businesses.
Lead the cascade of critical-to-quality features to downstream manufacturing and quality processes.
Support lifecycle management activities such as design changes and cost improvement initiatives.
Provide leadership in Quality System areas including corrective and preventive actions, product complaints, post-market surveillance, nonconforming materials, risk management, and audit support.
Communicate effectively within Quality and with Product Development, Regulatory, Manufacturing, and Marketing.
Communicate business-related issues or opportunities to the next management level.
Follow applicable laws, policies, regulations, standards, and compliance program requirements, maintaining professionalism, ethics, and compliance.
Ensure personal and Company compliance with applicable Federal, State, local, and Company regulations, policies, and procedures.
Perform other duties as assigned.