Ethicon, a part of the Johnson and Johnson family of companies, is currently recruiting a Primary Quality Engineer for the development of surgical robots and instruments in their Cincinnati, Ohio location.
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. This position will help grow and build a new J&J business unit, enabling significant professional growth.
You, the Primary Quality Engineer will be responsible for support more experienced Quality Engineer of the Quality Engineering activities within New Product Development.
- Support launch and stabilize new product launches through concept, design, development, and steady-state processes.
- With support from more experienced QE, drives the development of product requirements, verification strategies, and validation strategies.
- Ensures new product development compliance to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards
- Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
- Proactively engage stakeholders to drive consensus and resolve issues in a timely fashion.
- Provide statistical support and analytical problem solving for product development and manufacturing.
- Review and approve design control, manufacturing, quality, engineering and validation / qualification documents for conformance business practices and departmental procedures.
- Develop inspection and sampling plans, test methods, and transfer functions for products and components
- Provide support in developing and executing a reliability strategy during new product development.
- Conducts projects and assignments with technical responsibility based on guidance from more senior QE.
- A BS in engineering from an accredited engineering or relevant science / technical school is required.
- A minimum of 3 years of related work experience is required.
- Experience working in a regulated environment is required. Medical device industry is preferred.
- Experience with medical electrical-mechanical systems is an asset.
- Knowledge of Quality Engineering/Scientific methods and techniques and applied statistics of increasing complexity is preferred.
- 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.
- Previous work experience engaging in a team-based environment is required.
- ASQ Certified Quality Engineer, ASQ Certified Reliability Engineer, 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.
- This position will be located in Cincinnati, OH
- Moderate domestic and international travel of up
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)