Sr R&D Testing Engineer

Johnson & Johnson MedTech; Warsaw (IN); On-site; USD 92,000 - 148,000; Full time

Job summary

Johnson & Johnson MedTech in Warsaw, Indiana is seeking a Sr R&D Testing Engineer to perform mechanical, impaction, and materials testing supporting design verification and regulatory submissions. You will collaborate with R&D product development and Quality engineering in a hands-on lab environment.

The role requires a BS with 4+ years or MS/PhD with 2+ years in mechanical/materials/biomedical engineering, plus experience in regulated industries and statistical data analysis.

Qualifications

• Bachelor's degree in Mechanical Engineering, Materials Science and/or Engineering, Biomedical Engineering, or an equivalent program.
• Minimum of 4 years of experience (or MS/PhD with 2 years) in a related field.
• Minimum of 1 year experience in a regulated industry.
• Minimum of 1 year of testing experience.
• Experience with data processing and statistical analyses.
• Outstanding communication and technical writing skills.
• Attention to detail.
• Ability to independently perform hands-on lab work and supervise technicians/co-ops.
• Strong project management and organizational skills.
• Demonstrated problem solving capabilities.

Responsibilities

• Develop and ensure the testability of requirements; develop, qualify, and perform test methods verifying safety and efficacy of devices.
• Conduct investigational and verification tests to support product development, regulatory submissions, and quality investigations.
• Conduct research to improve product designs.
• Develop test methods including test plans, protocol development, instrument qualification, fixture development, test method validation, data analysis, reports, and summaries.
• Communicate test findings and proposed resolutions to teams.
• Provide technical support to business partners to improve device function, quality, and cost.
• Apply problem-solving and failure analysis skills to challenges.
• Follow lab practices and write/maintain technical reports and procedures.

Education

Bachelor’s degree in Mechanical Engineering, Materials Science and/or Engineering, Biomedical Engineering, or an equivalent program

Tools

Data acquisition systems

Transducers (load cells, LVDTs, strain gauges)

3D motion tracking / 3D optical test systems

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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

• 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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

Required 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

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.

Benefits

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