Job Function:
R&D Operations

Job Sub Function:
Product Development Testing

Job Category:
Professional

All Job Posting Locations:
Warsaw, Indiana, United States of America

Job Description:

About Orthopaedics

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that's reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for a Sr R&D Testing Engineer, located in Warsaw, Indiana

Purpose:

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.

Key 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.

Qualifications/Requirements:

Required:

• 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.

Preferred:

• 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.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Required Skills:

Preferred Skills:
Analytical Reasoning, Business Behavior, Clinical Data Management, Detail-Oriented, Execution Focus, Health Sciences, Innovation, Laboratory Operations, Market Research, Product Development, Product Improvements, Product Strategies, Product Testing, Project Management, Report Writing, Research and Development, Use of Laboratory Equipment

The anticipated base pay range for this position is :
$92,000.00 - $148,350.00

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

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits