Job Function: R&D Operations
Job Sub Function: Product Development Testing
Job Category:Professional
All Job Posting Locations:Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America
Job Description:About MedTechFueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
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..
You will be responsible for: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.
- 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.
Qualifications / Requirements:Education- Minimum of a Bachelor's degree or equivalent in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Material Science or other related fields
Experience and SkillsRequired:- 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
Preferred:- 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
- This position is located in Palm Beach Gardens, FL or Raynham, MA
- Up to 10% of time may be expected for domestic and international travel
#LI-Hybrid
Required Skills:Preferred Skills:The anticipated base pay range for this position is :$76,000.00 - $121,900.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
The following link to general company benefits information MUST also be included in the posting: Please use the following language:
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
