Ethicon is currently recruiting for a Senior Quality Engineer, Surgical Robotics, located in Cincinnati, OH.
Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made meaningful contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. This is an opportunity for a key role in bringing exciting new products to market to support the J&J / Google robotics venture. For more information, visit.
You, the Senior Quality Engineer will be responsible for support and leadership of Quality Engineering activities in New Product Development/ Process Introduction and Lifecycle/Business Improvement activities.
•Drive Verification and Validation strategies for new product development
•Providing New Product Team support for quality system design and audit
•Launch and stabilize new product launches through concept, design, development, and steady-state processes.
•Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
•Direct development & consistent application of quality policies & procedures in product design & development
•Provide support and expertise in developing and executing a reliability strategy during new product development.
•Stabilizing new product launches through steady-state manufacturing processes, change control, signal detection/escalation
•Apply advanced Quality Engineering/Scientific Method techniques/Six Sigma/Lean/ and Quality Tools to project tasks deliverables. Must have strong understanding of statistical methods and experience applying in product development and manufacturing processes
•Support quality engineering activities in development and maintenance of software for medical electrical systems.
•Develop inspection and sampling plans, test methods, and transfer functions for components and products
•Provide review and approval for the release of new products ensuring quality requirements are met provide leadership & support to J&J process excellence initiatives including Six-sigma, design excellence & lean thinking.
•Act as technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers.
•Proactively engage stakeholders to drive consensus and resolve issues in a timely fashion.
•A Bachelor’s degree in engineering from an accredited engineering or relevant science / technical school is required.
•A minimum of 5 years of related work experience is expected.
•Experience in a regulated industry (medical device) is preferred.
•Experience with medical electrical-mechanical systems an asset.
•Experience with human factors and clinical design validation is strongly preferred.
•Knowledge of Good Manufacturing Practices (GMPs) and ISO policy and procedures is preferred.
•Advanced knowledge of Quality Engineering/Scientific methods and techniques is preferred.
•Applied statistics of increasing complexity is required.
•New product development experience is required.
•Knowledge of FDA requirements for design control of medical devices, particularly with verification and validation of software for medical electrical equipment, strongly preferred.
•Assist teams in developing robust requirements traceable to customer requirements and in identifying critical-to-quality product and process elements is preferred.
•Conducting or contributing to the reliability assessments of product design is preferred.
•Conducting and supporting the development of test methods in equipment, process, and product qualifications/validations is preferred.
•Ensuring that process Quality control plans and Quality procedures are in accordance with product or process risk level and are consistently followed is preferred.
•Knowledge and understanding of statistical techniques such as capability measures, statistical process controls, process performance metrics, MSA, and test methods is required.
•Certified Quality Engineer from ASQ and a Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean) is preferred.
•Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms is an asset.
•Prior software quality engineering experience in a product development environment is an asset.
•Fundamental technical understanding of manufacturing equipment and processes is preferred.
•This position will be located in Cincinnati, OH
•Moderate domestic and international travel of up to 25%
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.
Ethicon Endo Surgery Inc (6041)