DePuy Synthes Companies of Johnson & Johnson, is recruiting for a Senior Project Engineer, New Product Development located in Warsaw, IN.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Senior Project Engineer, Product Development will design and develop new products. This individual will also develop improvements and modifications to current products. This individual will coordinate with surgeons, design engineers, manufacturing, regulatory affairs, sales consultants, product directors, and other functional departments to define and develop product requirements and concepts. The Senior Project Engineer, Product Development will work directly with surgeons for design concept development, prototype and cadaver evaluation, and clinical follow-up. This individual will give professional presentations in front of a Sales people and customers and monitors discussions of surgeons (e. g. in expert groups or surgeon’s labs). This individual will understand and follows the New Product Development process accurately and maintains high quality design validation and verifications. This individual will conceive, plan, and implement solutions to technical problems requiring unconventional approaches, new designs, and equipment and process development. The Senior Project Engineer, Product Development will generate product models, concept layouts, and prints using CAD software. This individual will apply geometric dimensioning and tolerancing accordingly. This individual will primarily work hands-on, with instruction or supervision of others secondary to own technical work when needed. The Senior Project Engineer, Product Development may lead sub-projects and assignments. This individual will design and execute mechanical tests and scientific experiments, present data and conclusions with appropriate analysis and write technical reports. The Senior Project Engineer, Product Development will independently determine and develop approaches to solutions with technical guidance on the most unusual or complex problems. This individual will have working knowledge of related disciplines. This individual will use their expertise to improve operational efficiencies and meet compliance requirements and operate within their budget. The Senior Project Engineer, Product Development will diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
Bachelor Degree in Engineering or related discipline; A minimum of 4 years of experience in product development or design control of mechanical products; A minimum of 1 year Project Management experience and/or leading technical projects; Demonstrated understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and GD&T ; Experience working in medical device regulations, including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO (International Organization for Standardization) quality requirements; Strong design quality experience with a proven track record in design verification/validation, process verification/validation, and design/process failure modes and effects analyses; Willing to work with cadavers and within an Operating Room setting; Proficiency utilizing the MS Office Suite (Word, Excel, and PowerPoint); Ability to travel up to 25% of the time.
An Advanced Degree; Experience with designing medical device or working in a machine shop environment; Knowledge of CAD software (Creo, Pro/Engineer, or Solid Works); Mechanical Engineering or Biomedical Engineering degree or demonstrated mechanics focus; Experience with implantable medical devices; Experience with plastic injection molding product and/or design-for-manufacturing; Knowledge of FDA 510(k) submissions process and regulation controls, and/or IDE clinical studies; Prior project management experience; A successful track record of working within a cross functional team bringing products from concept to launch;; Prior experience coaching, mentoring, train and developing staff.
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.
DePuySynthes Products Inc (6149)
R&D Engineering (R&D)