Cincinnati, OH, USJohnson & Johnson companies are equal opportunity employers.
FOD Staff Engineer-9738130509Description
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. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. 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.
Ethicon Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Engineer in the Franchise Operations Development organization, supporting the Endo-Mechanical & Energy Development Engineering to be based in Cincinnati, OH.
Duties and Responsibilities:
Lead/support NPD project to plan, design, develop, qualify, validate and stabilize end to end assembly process solutions.
Responsible for process characterization and control for component and assembly solutions
Provide input to NPD teams on Design for M, A , C and drive product development to enable robust product and process development that meets business commitments and stabilization metrics
Responsible for designing and developing robust equipment and processes to meet product requirements in compliance to Lean, Safety and Ergo requirements.
Incorporates risk mitigation methodology to drive process stability and capability
Develop Verification and validation strategies for end-to end process validation
Develop methods and test solutions for product verification and validation testing
Develop robust process solutions for polymer and metallic components, ensuring on time product launches and with low cost as a focus.
Plan, conduct & direct engineering assignments to completion.
Lead improvements to product quality and production processes on LCM projects
Development, qualification , validation and stabilization of plastic, metal components
Apply comprehensive & diverse knowledge of engineering principles to a broad range of assignments
Write and review documentation related to procedures, special instructions, qualification plans and reports, corrective action plans, etc
Deliver departmental goals and objectives for continuous improvement, Financial, and franchise initiatives.
Ability to function and drive the team to execute in ambiguous situations, with a sense of urgency
Experience working with external suppliers to drive component and assembly process solutions.
Pro-actively develop technology solutions to mitigate risk associated with NUD product requirements.
Ability to identify and translate work content associated with process development required for NPD projects into resourcing needs.
Support Project management activities of the Project leadership
Provide leadership and mentor less experienced engineering talent
Champion Systems development strategy and support operations strategy in end to end supply chain solution development
Responsible for the process development, verification and validation strategy and execution to the strategyQualifications
A minimum of a Bachelor's degree in Engineering is required, preferably in Mechanical, Material Science, Bio-Engineering, or Electrical Engineering discipline; Advanced Engineering degree is preferred.
A minimum of 7 years with a Bachelors or at least 5 years and a Masters of combined engineering experience in a regulated industry is required; Prior experience in R&D/ New product development is preferred
Previous experience in the area of Design for Manufacturing & Assembly (DFM & A) is required.
Experience within a medical device production environment or other health care regulated environment preferred
Demonstrated success in leading individuals and coordinating team activities in a matrix environment is preferred.
Prior project management experience required, PMP certification is desirable
Experience in equipment and assembly process development in CFM (Continuous Flow Manufacturing) environment is preferred.
Experience in the development and implementation of automated assembly systems along with experience with PLC, HMI and Vision controls preferred
Experience with metal component design, development, and production processes is preferred.
Experience with plastic component design, development, and production processes is preferred.
Experience in design, development, implementation and stabilization of Measurement Systems preferred.
A strong background in advanced Statistical Process Control (SPC) is required.
Experinece with mechanical and/or electro mechanical component development is required.
Knowledge of GD&T (ASME Y14.5, 1994) is required for application in NPD projects
Assembly process development is required.
Six Sigma / Process Excellence and/or Design Excellence experience is preferred. A Six Sigma / Design Excellence Certification is preferred.
Experience in Electro-Mechanical systems is preferred
Experience in CAD software (NX or Solid works) usage is preferred
Must be able to travel approximately 20% domestic and internationally (including Juarez, Mexico).
Strong analytical and problem solving skills
Demonstrated ability for teamwork and collaboration, strong attention to detail and having a sense of urgency.
Ability to delegate, coordinate and direct engineering assignments to team members and be accountable for their deliverables
Understanding of SCOR model of Supply Chain is preferred
Excellent communication and interpersonal skills required.
Knowledge of FDA/ISO requirements associated with the development of medical devices including Design Control preferred
Understanding of IP issues relative to processes being developed preferred.
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North America-United States-Ohio-CincinnatiOrganization:
Ethicon Endo Surgery Inc (6041)Job Function:
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