DePuy Synthes Spine, Inc a member of Johnson & Johnson's Family of Companies is recruiting for a Staff Mechanical Testing and Analysis Engineer to be located in Raynham, MA.
DePuy Synthes is a Johnson & Johnson company that is one of the leaders in the medical device industry. Our implants and instruments are used by orthopaedic surgeons to treat patients with conditions resulting from traumatic injuries, degenerative diseases, deformities, and sports related injuries. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will 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, we are creating one organization that will be agile and better equipped in 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 individual contributes to the design characterization, verification and risk assessment of spinal implants and instrumentation. This includes communication with multiple disciplines, understanding of clinical issues, defining the clinically relevant testing parameters and applicable industry standards, and ensuring results are provided to the teams. This role will require the management of others within the group performing a similar role.
The Staff Engineer will be responsible for the mechanical testing aspects of a project, participating on cross-functional project team through all phases of the product development process, and assisting the technical team with planning executing, documenting and communicating testing activities: These activities include:
- Ability to manage multiple projects and direct reports
- Mentor others to solve technical problems related to fixturing, test methodology, unexpected failures and challenging test setups
- Mentor others in assessing the effect of design changes on mechanical performance, creation of guidance documents, decision trees and best practices
- Clearly and professionally communicate test findings, technical challenges, and proposed resolutions to teams and management
- Ability to manage lab resources, people and equipment and communicate performance metrics and potential bottlenecks to management
- Ability to review, understand and provide suggestions on complex testing documentation including data analysis and statistical methods
- Interpret industry (ASTM) & company standards and author test methods that are consistent and compliant
- Analysis of data using complex statistical tools and Six Sigma Design Tools (Gauge R&R, DOE, Weibull Distributions)
- Active contribute and review of test plans and risk assessments (DFMEA)
- Plan, direct, and conduct laboratory and field testing of products
- Conduct the testing including:
- Configuration of hardware (Instron, MTS)
- Software (Partners, Bluehills) to meet testing requirements
- Design & direct construction of test systems to simulate use for verification & durability testing
- Oversee and review the design of fixturing & testing layouts utilizing CAD tools
- Review complaint investigation documentation that utilizes fracture analysis techniques including SEM
- Document lab activities utilizing good documentation practices (GDP)
- Ability to work with Project Management, Quality, Product Development, Regulatory or Manufacturing Engineers. Will also be asked to perform other duties as requested.
The candidate should demonstrate proficiency in leading a team with aspects of the project management functions including scope definition, and contingency planning. The candidate should have a demonstrated ability to prioritize tasks and manage a varied workload, exhibit strong written and verbal communication skills and interface effectively with project teams, management and surgeons. The individual will also be expected to have a working knowledge of our product lines and detailed knowledge of various spinal pathologies. This candidate should demonstrate the ability to lead and develop people either directly or indirectly while balancing these activities with their individual workload.
- A minimum of a Bachelor’s degree in Mechanical Engineering or Biomedical Engineering is required. A Master’s Degree is desired. Electrical and Mechanical Experiencepreferred
- A minimum of 6 years of medical test engineering or equivalent relevant experience is required.
- Experience/working knowledge in static and cyclic testing, data acquisition, and general test engineering methodologies is required.
- Knowledge of ASTM Standards preferred.
- Experience with medical devices (Spine or Orthopedic) is highly preferred.
- Strong track record utilizing statistics for purposes of testing products is required.
- Experience with Design Excellence/ Six Sigma methodologies such as Gauge R&R, Weibull Distributions and/or DOE is highly preferred.
- Demonstrated understanding of various types of manufacturing, mechanisms, materials, and test equipment are required.
- Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint, project etc) and Mini-Tab is required.
- Ability to lead and develop others is required
- Experience working with CAD, specifically Unigraphics or Pro-E is desirable
- Must have the ability to effectively communicate concepts, ideas and knowledge to other individuals, surgeons, and/ or product teams, and work effectively as a team member with in the research and testing group.
- Prior experience reviewing and critically assessing testing documentation and laboratory documentation is required.
- Ability to multitask with excellent attention to detail.
- This position will be based in Raynham, MA and 10% travel.
Requisition ID: 6955180322