Systems Test Engineer

Johnson & Johnson • Raynham, MA

1d • $76,000 - $121,900 • Hybrid

About The Position

The Systems Test Engineer contributes with limited guidance to the research, design characterization, verification and risk assessment of medical implants and instrumentations for mechanical and electro-mechanical 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.

Requirements

• Minimum of a Bachelor’s degree or equivalent in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Material Science or other related fields
• Minimum of 2 years’ experience in the Medical Device industry
• Minimum of 1 years’ experience with servo-hydraulic and/or electromechanical test equipment
• Experience with transducers (load cells, LVDT’s, strain gages, etc.) and data acquisition systems is required
• Prior experience with medical device capital equipment 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
• Prior experience with lab instrumentation and complex measurements on electro-mechanical and fluidic systems
• Good Laboratory Practice/ Good Documentation Practice
• Verbal and written communication skills
• Statistical analysis
• Problem analyzing and solving
• Ability to effectively work on multiple tasks

Nice To Haves

• Prior experience or general knowledge in electro-mechanical fixture development and qualifications is required
• Experience with 3D motion tracking systems or 3D optical test/inspection systems is preferred
• Ability to develop testing/analysis software scripts in Python, MATLAB, C++ or other scripting languages 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

Responsibilities

• 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.
• 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 Systems 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.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level