Research & Development 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 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 Product Development

Job Sub Function:

Biomedical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

West Chester, Pennsylvania, United States of America

Job Description:

We are searching for the best talent for a Research & Development Engineer, to join our Orthopaedics team. This is a hybrid role located in West Chester, PA.

Purpose:

The Research & Development Engineer will help lead the design and development of new implants and instrumentation and/or support in-market products through their product life cycle within a cross-functional project team. This includes communication with customers, e.g., Health Care Professionals and marketing, understanding of clinical issues, defining the design parameters, and ensuring the product which is provided to the customer meets functional requirements.

The role will be responsible for the design and development aspects of a project, participating on cross-functional project teams through all phases of the product life cycle, and assisting the project leader with planning and executing projects or portions of a project through product launch, commercialization, and post market surveillance.

Key Responsibilities:

• Technically lead design and development projects with oversight, and will work closely with the project leader, members of the project core team (marketing, manufacturing, quality, testing, supply chain, regulatory, etc.)
• Engage Health Care Professionals and other functional departments to define user needs and design inputs
• Solve design problems utilizing CAD techniques, rapid and conventional prototyping, and other available technologies
• Develop layouts and tolerance studies utilizing GD&T, and will participate in performing design evaluations (such as FEA, simulated use testing, dry labs and wet tissue/cadaver labs etc.)
• Development and execution of design verification/validation plans, test methods and protocols, and will support regulatory processes for global registration efforts.
• Performs the required activities and generate the appropriate documents to ensure compliance with MDR, FDA Design Control regulations, and to support 510(k) submissions or IDE clinical studies
• Work with supply chain and manufacturing engineering and/or suppliers to optimize designs for manufacturability and assembly to produce functioning prototypes and supporting production documentation
• Demonstrate proficiency in the application of design controls and development processes and support the project leader with aspects of the project management functions including scope definition, and contingency planning
• Perform complaint investigations and field investigation activities in support of patient/customer safety
• Will be responsible for initial patent review of designs for freedom to operate.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics, and compliance at all times
• Responsible for communicating business-related issues or opportunities to next management level

Required Qualifications:

• BS in Mechanical Engineering, Biomedical Engineering, or equivalent
• 2-6 years of experience in the design and development of medical devices, mechanical products, or biomechanical systems
• “Hands on” Engineering experience
• Experience with CAD software (Pro-E, Creo, SolidWorks, etc.)
• Understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and GD&T
• Ability to work with wet tissues/cadaver and within an Operating Room setting
• Demonstrated success in bringing products from design through introduction on time
• Strong communication and interaction skills, with the ability to interface with Health Care Professionals and sales/marketing personnel
• Strong problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations
• Demonstrated creative design ability
• Demonstrated ability to prioritize tasks and manage a varied workload

Preferred Qualifications:

• Master’s degree in Mechanical Engineering, Biomedical Engineering, or equivalent

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