Sr R&D Testing Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we innovate across the full spectrum of healthcare solutions to deliver breakthroughs that profoundly impact health for humanity.

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. Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. We 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.

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.

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 the 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.
• Ensure personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.
• Perform other duties assigned as needed.

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 of 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 convey 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.

Skills

• 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.

Pay

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

Benefits

• 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.
• 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.
• 10 days Volunteer Leave – 32 hours per calendar year.
• Military Spouse Time-Off – 80 hours per calendar year.