Johnson & Johnson Careers
Design Quality Engineer II
West Chester, Pennsylvania
Requisition ID: 3563190430
DePuy Synthes is looking for a Design Quality Engineer II located in West Chester, PA.
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.\
We are looking for a Design Quality Engineer II to support the New Product Development (NPD) Quality Group for the Trauma/CMF business. You should excel in an environment that embraces teamwork, change, risk-based decision-making, and flexibility. You should be willing to make a meaningful contribution to a multi-discipline team, be self-motivated to take action, and have excellent written and verbal communication skills.
• NPD team member focused on product development and life cycle management activities related to the DePuy Synthes Trauma/CMF business.
• Lead the cascade of critical to quality design features to product quality plans and downstream manufacturing & quality processes.
• Work closely with suppliers on the qualification of new parts and processes supporting product development.
• Lead design and development planning activities for new R&D projects.
• Participate in all aspects of the creation and execution of functional/design requirements for new products.
• Conduct formal technical design reviews throughout the phases of the product development process.
• Support and approve design verification/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 & clinical risk management, production risk management, and overall risk summary reporting.
• Improve the design control and risk management processes to better reflect state of the art practices and drive continuous improvement.
• Provide 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.
• Provide leadership in the understanding of medical device regulations to other disciplines.
• Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Research & Development, Regulatory, Manufacturing, Supply Chain, and Marketing.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of integrity, ethics and compliance at all times.
• Diligently participate in our compliance program related activities as denoted by your supervisor or our Chief Compliance Officer. Additional duties as assigned.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
• Bachelor’s Degree in Engineering and/or in a Technical Science is required.
• A Master’s Degree is a plus.
• A minimum of 2 years related working experience in a GMP and/or ISO regulated industry is required.
• Strong design/quality engineering skills with a proven track record in all areas of the design control process, including functional/design requirements, design verification/validation, and product risk management required.
• Excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations required.
• Proven track record implementing Quality System improvements to meet compliance and overall business goals preferred.
• Proficiency with the Microsoft Office Suite is required.
• Previous experience in a medical device or a healthcare discipline is strongly preferred.
• Strong working knowledge of QSR (21 CFR 820) and ISO (13485, 14971) quality requirements is strongly preferred.
• Manufacturing drawing literacy including GD&T is preferred.
• Knowledge of process and design excellence tools is preferred; Certification is a plus.
• This position is based in West Chester, PA and will require up to 10% travel, including potential international.
United States-Pennsylvania-West Chester-
Depuy Orthopaedics. Inc. (6029)