Johnson & Johnson Karrieren
Staff Design Quality Engineer
Requisition ID: 1805652510W
DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
The Staff Design Quality Engineer will be supporting the Product Development Group for the Power Tools business. The qualified candidate for this hands-on position should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. This individual should be willing to make a significant contribution to a multi-discipline team, must be self-motivated to take action, and have excellent written and verbal communication skills.
POSITION DUTIES & RESPONSIBILITIES:
- Product development team member focused on product development and life cycle management activities related to the Power Tools business.
- Lead design and development planning activities for new and sustaining projects.
- Participate in all aspects of the creation and execution of functional/design requirements for new and sustaining projects.
- 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 basic and advanced statistical methods and design excellence tools to design verification and validation activities (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.).
- Support risk management activities including planning, design & clinical risk management, production risk management, and overall risk summary reporting.
- Lead the cascade of critical to quality design features to product quality plans and downstream manufacturing & quality processes. Support transfer to manufacturing activities both in product development and base businesses.
- Enhance 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 Product Development, Regulatory, Manufacturing, and Marketing.
- Work closely with suppliers on the qualification of new/changed parts and processes supporting product development. This person will conduct assessments of new suppliers as part of the project teams.
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, 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.
PROFESSIONAL EXPERIENCE REQUIREMENTS:
· Minimum related working experience in a GMP and/or ISO regulated industry: 6 years with Bachelor’s, 5 years with Master’s or 3 years with PhD.
· Strong design/quality engineering skills with a proven track record in all aspects of the design control process, including functional/design requirements, design verification/validation, and product risk management 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.
· Blueprint literacy including GD&T preferred.
· Knowledge of process and design excellence tools is strongly preferred. Certification is a plus.
· Interpersonal skills that foster conflict resolution as it relates to technical situations.
· Candidate should possess 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.
· Candidate should have a proven track record implementing Quality System improvements to meet compliance and overall business goals. Proficiency with the Microsoft Office Suite is required.
· A minimum of a Bachelor Degree in Engineering and/or in a Technical Science is required. A Master’s degree is a plus.
Synthes GmbH (7111)