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
• Works 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 in 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 is required
• Prior experience with medical device joint simulators is highly preferred
• Experience with data processing and statistical analyses is required
• Experience with technical writing is required
• Prior experience writing plans/protocols and performing formal testing in a regulated industry is required·
• 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 is required
• Experience with 3D motion tracking systems or 3D optical test/inspection systems is preferred
• Experience with instrument qualification and validation activities
• Experience working in an agile project management environment
• Experience with PLM applications
• Knowledge of regulatory guidelines is preferred

Other:

• Up to 10% of time may be expected for domestic and international travel

Required Skills:

Preferred Skills: