Design Quality Engineer I

Johnson & Johnson Innovative Medicine•West Chester, PA

6d•Onsite

About The Position

This role will support the Design Quality Engineering Group for the Trauma, Extremities, Craniomaxillofacial (CMF), and Animal Health businesses with the objective of launching and sustaining orthopaedic implants and associated instrumentation. This position contributes directly to product development, innovation, and lifecycle support by applying technical knowledge to ensure product performance, safety, and regulatory compliance. The role offers the opportunity to influence next‑generation solutions that improve patient outcomes while collaborating across R&D, Quality, Regulatory, and Manufacturing teams.

Requirements

B.S. in Engineering and/or in a Technical Science is required
Minimum of 1 year experience in a GMP and/or ISO regulated industry is required (this includes internships, co-ops, practical experience).
Proficiency with the Microsoft Office Suite
English (fluent)

Nice To Haves

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

Responsibilities

Product development and life cycle management activities related to the Trauma and CMF business.
Leading product realization planning activities for new projects and previously launched products, including conducting formal technical design reviews throughout the phases of the product realization process, supporting design verification/validation activities including mechanical testing, tolerance analyses, design rationales, and surgeon based anatomical labs.
Applying statistical methods and design excellence tools to design verification and validation activities.
Supporting risk management activities including planning, design & clinical risk management, production risk management, and overall risk benefit reporting.
Working closely with suppliers on the qualification of new parts and processes and supporting transfer to manufacturing activities both in product development and base businesses, and leading the cascade of critical to quality features to downstream manufacturing and quality processes.
Supporting product life cycle management activities such as design changes and cost improvement initiatives.
Providing leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions.
Communicating effectively at all levels within Quality, as well as with departments such as Product Development, Regulatory, Manufacturing, and Marketing.
Responsible for communicating business related issues or opportunities to next management level.
Knowing and following all laws and policies that apply to one's job, and maintaining the highest levels of professionalism, ethics, and compliance at all times.
Following regulations and standards and diligently participating in our compliance program-related activities
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performing other duties assigned as needed.