Job Description
DePuy Synthes is recruiting for a Senior Kinematics Test Engineer, located in Leeds, UK.
The Senior Test Engineer contributes with limited guidance to the research, design characterization, verification and risk assessment of medical implants and instrumentations for Kinematic/Tribological applications. The engineer will work closely with R&D engineering and Quality engineering to develop and ensure the testability of requirements, while developing test methods that will holistically verify the safety and efficacy of the medical devices (implants and instrumentations). This is a hands-on engineering role which touches on various engineering fields required for formal testing of complex medical devices and systems. Additionally, the individual will have the opportunity to propose improvements to our existing processes to improve the team's quality and efficiency.
Key Responsibilities
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position:
•Perform verification tests to support regulatory submissions, investigational tests to support new product development and quality investigations, and research to improve product designs
•Develop test methods that meet complex requirement intent (including but not limited to: test plans, protocol development, fixture development, test method validation, data analysis, test report and summary document generations)
•Clearly and professionally communicate test findings, technical challenges and proposed resolutions to teams
•Work with development engineers, manufacturing, regulatory affairs, product directors, equipment and materials vendors and other team members to develop and execute test protocols, creating technical reports and contribute to peer reviewed publications in multi-functional projects
•Mentor students and other technical staff
•Participate in the review processes for function of current and new product (including investigative skills to evaluate customer complaints) and contribute to design FMEAs and process PFMEAs
•Must be able to work individually and as part of a team in development projects, possibly leading internal projects with a strong test/research bias
•Must be effective in cross functional projects and work in a global team and execute test procedures in line with company/international procedures/specific country requirements to generate data required for the design verification section of the product development and design history files (DHF)
•The Senior Test Engineer will take the lead in understanding, revising, and implementing departmental work instructions to ensure consistency in all DePuy Synthes laboratories
•Assist with departmental internal and external quality audits to ensure compliance and remediation
Qualifications
Education:
•Minimum of a Bachelor's degree or equivalent in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Material Science or other related fields
Experience and Skills — Required:
•Minimum of 4 years' experience in the Medical Device industry
•Minimum of 2 years' experience within Tribology
•Experience with transducers (load cells, LVDT's, strain gages, etc.) and data acquisition systems
•Prior experience with medical device joint simulators is highly preferred
•Experience with data processing and statistical analyses
•Experience with technical writing
•Prior experience writing plans/protocols and performing formal testing in a regulated industry
•Good Laboratory Practice / Good Documentation Practice
•Verbal and written communication skills
•Statistical analysis
•Problem analyzing and solving
•Ability to effectively work on multiple tasks
Preferred:
•Prior experience or general knowledge in fixture development and qualification
•Experience with 3D motion tracking systems or 3D optical test/inspection systems
•Experience with instrument qualification and validation activities
•Experience working in an agile project management environment
•Experience with PLM applications
•Knowledge of regulatory guidelines
Other:
•Up to 10% of time may be expected for domestic and international travel
Benefits
As part of the offering, you will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life, including: online Digital GP, private healthcare, Retail Vouchers, Discounted & Subsidised Gym memberships, and the opportunity to support community projects as part of the global Corporate Social Responsibility programme.
