Description
DePuy Synthes, part of Johnson & Johnson's MedTech, is recruiting for a Test Engineer located in Warsaw, IN.
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 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
The Research and Test Engineer will provide a professional level of expertise and knowledge in the areas of biomechanical testing and research of orthopaedic implants and instrumentations, related to new product verification testing, research, and analysis of field failures. The engineer will maintain impaction equipment and perform impact investigational and verification tests of instruments to support internal requirements and regulatory submissions. The engineer will analyze and critique designs in prototype development stages to provide a functional test of efficacy. The Research and Test Engineer needs to stay current with advances in orthopaedic surgery, biomechanics, and biomaterials. They need an understanding of impact physics, mechanics, materials, international standards and bioengineering in both the industrial and academic fields. Additionally, investigative and research skills are required to support clinical relevance.
Key Responsibilities:
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.
Perform investigational tests to support new product development and quality investigation.
Conduct research to improve product designs.
Participate in cross functional projects.
Work with development engineers, manufacturing, regulatory affairs, product directors, equipment and materials vendors, and other team members to develop and execute test and simulation protocols, creating technical reports and contribute to peer reviewed publications.
Participate in the review processes for the function of current and new products (including investigative skills to evaluate customer complaints) and contribute to design FMEA's and process PFMEA's.
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 with 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).
Lead in understanding, revising, and implementing departmental work instructions to ensure consistency in all DePuy Synthes laboratories.
Perform instrument/equipment installation qualifications, test method validations, and software validations as applicable to developing testing methodologies.
Assist heavily with departmental internal and external quality audits to ensure compliance and remediation.
Qualifications
Education:
Minimum of a Bachelor's degree or equivalent in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or other related disciplines
Required
Minimum of 1-2 years related industry experience or Master's degree.
Prior experience with lab test equipment.
Experience of data acquisition (DAQ) systems and sensors (strain, voltage, load, displacement).
Experience with high-speed data acquisition and processing.
Ability to use computer and laboratory equipment and software, perform statistical data analysis and test results interpretation.
Ability to independently plan and perform hands-on lab work.
Strong project management and organizational skills.
Demonstrated problem solving capabilities.
Outstanding communication and technical writing skills to communicate highly technical concepts and data to diverse technical and non-technical partners.
Highly motivated and enthusiastic self-starter that works under own initiative and as an extraordinary teammate.
Preferred:
Prior experience with pneumatic test equipment.
Knowledge of impact physics.
Knowledge of surgical impaction in orthopedic industry.
Experience with impact testing of medical devices.
Experience in Controls systems and PLC programming.
Medical device/instruments or failure analysis experience.
Knowledge of current ASTM/ISO test standards and ISO 17025 accreditation.
Knowledge of regulatory guidelines.
Other:
Travel: 10% travel mostly domestic possibly international.
For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $70,000 to $100,000. Additional information can be found through the link below. For additional general information on company benefits, please go to:
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.