The Ethicon Surgical Care
business a member of Johnson & Johnson's Family of Companies, is currently
recruiting for a Staff Quality Engineer, Systems Engineering 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 leadership and support of Quality Engineering activities in the Systems Engineering group.
- Partner with Systems Engineering organization to drive consistency across new product development teams through concept, design, development and steady-state processes.
- Support activities in development and maintenance of software for medical electrical systems including applicable external standards.
- Support development of product requirements and Verification & Validation strategies.
- Direct development & consistent application of quality policies and procedures in product design & development
- Proactively engage stakeholders to drive consensus and resolve issues in a timely fashion
- Resolve internal and external sources of requirements (e.g. regulatory standards, risk management processes).
- Provide statistical support and expertise in DOE (Design of Experiments) and analytical problem solving for product development, manufacturing, and technical services.
- Review and approve manufacturing, quality, engineering and validation / qualification documents for conformance business practices and departmental procedures.
- Perform analysis of documents / information to ensure that all critical product characteristics have been identified and properly evaluated.
- 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 expected. Experience in medical device industry is expected. New product development experience is required.
- Embedded software and/or software controls in a product development environment is an asset. Experience with medical electrical-mechanical systems is an asset.
- Experience with Systems Engineering is preferred.
- Knowledge of Good Manufacturing Practices (GMPs) and ISO policy and procedures is preferred. Knowledge of FDA requirements for design control of medical devices, particularly with verification and validation of software for medical electrical equipment, strongly preferred.
- Advanced knowledge of Quality Engineering/Scientific methods and techniques. Applied statistics of increasing complexity is required.
- ASQ Certified Quality Engineer, ASQ Certified Software Quality 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.
- Experience with human factors and clinical design validation is preferred.
- Previous work experience engaging in a team-based environment is required.
- This position will be located in Cincinnati, OH
- Moderate domestic and international travel of up to 25%
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Ethicon Endo Surgery Inc (6041)