Senior Engineer Design Quality

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: R&D/Scientific Quality Job Category: Professional All Job Posting Locations: Zuchwil, Switzerland Job Description: Please note that a preferred candidate has been identified for this position. Applications received will be reviewed and considered in accordance with our recruitment process. Purpose: Develops standard operating procedures, specifications, and provides technical transfer and validation support. Minimizes sample and scrap waste, assesses reliability and risks based on validated data, identifies root causes of problems, and reduces or eliminates sources of variation. Audits and approves manufacturing, quality, engineering and validation documents for conformance to business practices and departmental procedures. Provides data and documentation in support of the development of validation strategies. Acts as liaison to the regulatory affairs department to perform initial regulatory review of all engineering changes and modifications to products. Provides sampling plans and approves inspection methods for evaluation and testing of components and products. Provides support and expertise in reliability planning and reliability growth demonstration during new product development. Support the New Product Development Design Quality Group for the TECA business, mainly for launching orthopedic implants and associated instrumentation. Significant contributor to a multi-discipline team in all aspects of the Quality System and provides overall quality assurance leadership in the management of selected contract manufacturing sites engaged in the production of DePuy Synthes products. Supports the selected contract manufacturing sites in validation, risk management, product quality issue resolution and escalation, and quality systems performance monitoring for new product development introduction at the manufacturing sites. You will be responsible for: Product development team member focused on product development and life cycle management activities related to the Trauma/CMF business. Lead design and development planning activities for new projects. Participate in all aspects of the creation and execution of functional/design requirements for new 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 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 benefit 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. Support product life cycle management activities such as design changes and cost improvement initiatives. Enhance the design control and risk management processes to better reflect