Ethicon Surgical Care business a member of Johnson & Johnson's Family of
Companies, is currently recruiting for a Staff Quality Engineer, New Product
Development, Surgical Robotics located in Cincinnati, OH.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. The Ethicon Surgical Care business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today. This is an opportunity for a key role in bringing exciting new products to market to support the J&J / Google robotics venture. Ground-floor position to help grow and build a new J&J business unit, enabling significant professional growth.
You, the Staff Quality Engineer will be responsible for support and leadership of Quality Engineering activities in New Product Development activities.
- Launch and stabilize new product launches through concept, design, development, and steady-state processes.
- 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 expertise in DOE (Design of Experiments) 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 and expertise in developing and executing a reliability strategy during new product development.
- Plans and conducts projects and assignments with technical responsibility and strategic input.
- A BS in engineering from an accredited engineering or relevant science / technical school is required.
- A minimum of 6 years of related work experience is required. Experience in medical device industry is required. Experience with medical electrical-mechanical systems is an asset.
- Advanced knowledge of Quality Engineering/Scientific methods and techniques and 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.
- 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
Ethicon Endo Surgery Inc (6041)