DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior R&D Product Development Engineer, Front-End located in West Chester, PA.
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.\
The Front-End team generates creative solutions to real-world needs that directly benefit patients, while meeting growing business challenges. As part of our talented and passionate team, you will tenaciously drive the development of new technologies for orthopaedic devices from concept to commercialization. With relentless focus on customers, you will work with global product development teams, marketing, and supply chain groups to identify and develop new technologies, materials and processes to drive cost-effective and differentiated medical devices of the highest quality. As part of our team, you will get to lead and perform hands-on characterization and testing work on new-to-us technologies of value to our business. You will have opportunities for training and engagement with experts across the company and the scientific community to develop premier technical skills.
� Act as a technical team leader and in some cases project leader as a member of a cross-functional project core team (marketing, manufacturing, quality, testing, supply chain etc.).
� Engage surgeons to define user needs, design inputs, and new surgical techniques.
� Solve complex design problems utilizing CAD techniques, rapid and conventional prototyping and other available technologies. Generate design concepts and prototypes independently.
� Perform design evaluations (such as tolerance analysis, FEA, simulated use testing, dry labs and wet tissue labs etc.) Document clinical and surgical technique observations to create meaningful design solutions.
� Development and execution of design verification and validation plans and activities, and test plan formation and execution to support global regulatory strategy.
� Drive initial patent review and freedom to operate activities from concept to launch.
� Collaborate with manufacturing engineering and/or suppliers to optimize designs for manufacturability and assembly to produce functioning prototypes and supporting production documentation
� Demonstrate proficiency in the application of design controls and development processes and support the project leader with aspects of the project management functions including scope definition, and contingency planning.
� Act as an expert on existing product lines and detailed knowledge of applicable anatomic pathologies.
� Perform complaint investigations and field investigation activities in support of patient/customer safety.
� Perform quality/compliance activities in support of audits, remediation projects, non-conformances, regulatory compliance projects.
� Support Operations projects associated with Cost Improvement Projects and Production Transfers.
� Performs other special projects and functions as assigned.
� Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
� Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
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.
� Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, or related field required.
� A Master's degree is preferred.
� 5 years of experience in the design and development of medical devices, mechanical products, or biomechanical systems, including multi-component systems, is required.
� Strong experience with CAD software (Pro-E, Creo, Solidworks, etc.) required.
� Experience in identifying user needs (VOC), medical device design principles, material selection, ability to verify and validate design concepts, and understand design failure modes is required.
� Demonstrated understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and GD&T are required.
� Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint, etc.) is required.
� Willingness to work with cadavers and within an Operating Room setting is required.
� Strong communication and interaction skills, with the ability to interface with surgeons and sales/marketing personnel required.
� Strong organizational & project leadership skills to support all aspects of a multi-faceted project required.
� Demonstrated creative design ability required.
� Must have the ability to effectively communicate concepts, ideas and knowledge to other individuals, surgeons, customers and/ or teams, and work effectively as a technical leader and sometimes as a project leader required.
� Experience in medical device industry and knowledge of Regulatory Design Controls is highly preferred.
� Project management functions including scope definition, budgeting, and contingency planning preferred.
� The ability to review and critically assess patents and other forms of intellectual property is preferred.
� This position may require up to 20% travel including international.
In addition, working in the Front-End group requires the ability to work on multi-disciplinary projects, that may include various sensor technologies, wireless communications, data acquisition, or programming. This individual does not need to demonstrate expertise in these fields, but familiarity and basic experience in one or more of the following areas is considered an asset:
� General electromechanical experience
� Knowledge or experience with MEMS technology
� Basic experience programming in LabView or Matlab
� Basic understanding of various sensor technologies (e.g., acceleration, position, gyroscope, optical, etc)
� Basic knowledge in signal processing, data acquisition, and filtering techniques
United States-Pennsylvania-West Chester-
Synthes USA Products, LLC (6317)
R&D Engineering (R&D)