Sr R&D Testing Engineer

Johnson & Johnson Innovative Medicine•Warsaw, IN

2d•$92,000 - $148,350•Onsite

About The Position

The R&D Testing Engineer will perform mechanical, impaction, and/or materials testing to assess various properties and the performance of implants and instruments. Testing will support characterizations, design verification, risk assessment, and supplier changes of orthopedic implants and instruments. This includes communication with multiple partners, knowledge of testing apparatus and methodology, and data reporting with statistical analysis. This role will work closely with R&D product development and Quality engineering. This is a hands-on engineering role which touches on various engineering subject areas required for formal testing of complex medical device systems. Additionally, you will have the opportunity to propose improvements to our existing processes to improve the team’s quality and efficiency.

Requirements

Bachelor’s degree with a minimum of 4 years of experience, or an advanced degree such as MS or Ph.D. with 2 years of experience. Degree in Mechanical Engineering, Materials Science and/or Engineering, Biomedical Engineering, or an equivalent program.
Minimum of 1 year experience in a regulated industry
Minimum of 1 year of testing experience
Experience with data processing and statistical analyses is required
Outstanding communication and technical writing skills to communicate highly technical concepts and data to diverse technical and non-technical partners.
Attention to detail is vital.
Ability to independently perform hands-on lab work, as well as to direct technicians and co-ops, in an R&D lab.
Strong project management and organizational skills.
Demonstrated problem solving capabilities.

Nice To Haves

Knowledgeable of materials and processes applicable to medical devices.
Prior experience with testing of medical devices is desirable.
Experience with transducers (load cells, LVDT’s, strain gages, etc.) and data acquisition systems is preferred
Experience with 3D motion tracking systems or 3D optical test/inspection systems
Ability to conceptualize and model test fixtures is preferred
Failure analysis experience is preferred.
Knowledge of current ASTM/ISO test standards is preferred
Knowledge of regulatory guidelines is preferred
Knowledge of impaction physics and impact testing of surgical instrumentation is preferred
Highly motivated and enthusiastic self-starter that works under own initiative and as an extraordinary teammate.

Responsibilities

Develop and ensure the testability of requirements; developing, qualifying, and performing test methods that will holistically verify the safety and efficacy of the medical devices (implants and instruments).
Perform investigational and verification tests to support new product development, regulatory submissions, and quality investigations
Conduct research to improve product designs
Develop test methods that meet complex requirement intent (including but not limited to: test plans, protocol development, instrument qualification, fixture development, test method validation, data analysis, test reports, and summary document generations)
Clearly and professionally communicate test findings, technical challenges, and proposed resolutions to teams
Communicate business related issues or opportunities to next management level
Provide technical support to business partners to improve device function, quality, and cost
Apply problem-solving and failure analysis skills to collaboratively solve technical challenges
Use good laboratory and documentation practices to perform hands-on testing
Write and maintain technical reports, work instructions, test methods, and procedures.
Follow all Company guidelines related to Health, Safety and Environmental practices as applicable.
Ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
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