Johnson & Johnson Careers
Senior Project Engineer
Requisition ID: 6028181030
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.
This position will be dependent upon the successful conclusion of the transaction between DePuy Synthes and Medical Enterprises Distributors, LLC.
The Senior Project Engineer, Product Development will be responsible for:
- Design and develop new products.
- Develop improvements and modifications to current products.
- Coordinate with surgeons, design engineers, manufacturing, regulatory affairs, sales consultants, product directors, and other functional departments to define and develop product requirements and concepts.
- Work directly with surgeons for design concept development, prototype and cadaver evaluation, and clinical follow-up.
- 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).
- Understands and follows the New Product Development process accurately and maintains high quality design validation and verifications.
- Conceives, plans, and implements solutions to technical problems requiring unconventional approaches, new designs, and equipment and process development.
- Generate product models, concept layouts, and prints using CAD software.
- Apply geometric dimensioning and tolerancing accordingly. Will primarily work hands-on, with instruction or supervision of others secondary to own technical work when needed.
- May lead sub-projects and assignments. Will design and execute mechanical tests and scientific experiments, present data and conclusions with appropriate analysis and write technical reports.
- Will independently determine and develop approaches to solutions with technical guidance on the most unusual or complex problems.
- Use their expertise to improve operational efficiencies and meet compliance requirements and operate within their budget.
- Diligently participate in our compliance program-related activities.
- Bachelor Degree in Engineering or related discipline is required
- A minimum of 4 years of experience in product development or design control of mechanical products is required
- A minimum of 1 year Project Management experience and/or leading technical projects; is preferred
- 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 are required
- Strong design quality experience with a proven track record in design verification/validation, process verification/validation, and design/process failure modes and effects analyses is required
- Willing to work with cadavers and within an Operating Room setting; is required
- Proficiency utilizing the MS Office Suite (Word, Excel, and PowerPoint); Ability to travel up to 15% of the time is required
- An Advanced Degree such as Mechanical Engineering or Biomedical Engineering degree is preferred
- Experience with designing medical device or working in a machine shop environment; Knowledge of CAD software (Creo, Pro/Engineer, or Solid Works); or demonstrated mechanics focus is preferred
- Experience with implantable medical devices is preferred
- Experience with plastic injection molding product and/or design-for-manufacturing is preferred
- Knowledge of FDA 510(k) submissions process and regulation controls, and/or IDE clinical studies is preferred
- Prior project management experience is preferred
- A successful track record of working within a cross functional team bringing products from concept to launch is preferred
- Prior experience coaching, mentoring, train and developing staff is preferred
DePuySynthes Products Inc (6149)
R&D Engineering (R&D)