Product Development Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

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About Orthopaedics

Fueled by innovation at the intersection of biology and technology were 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 thats 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 are searching for the best talent for Product Development Engineer to work from West Chester PA location in a hybrid role.

Purpose:

The R&D Engineer 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.

• Knowledge of existing product lines and detailed knowledge of applicable anatomic injuries/pathologies as well as treatment options

• Understands and follows the New Product Development process accurately.

• Perform complaint investigations and field investigation activities in support of patient/customer safety.

• Support/Perform quality/compliance activities in support of audits remediation projects non-conformances regulatory compliance projects.

• Will be responsible for initial patent review of designs for freedom to operate.

• Support Operations projects associated with Cost Improvement Projects and Production Transfers.

• Performs other special projects and functions as assigned.

• Know and follow all laws and policies that apply to ones job and maintain the highest levels of professionalism ethics and compliance at all times.

• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.

• Responsible for communicating business related issues or opportunities to next management level.

• For those who supervise or manage a staff responsible for ensuring that subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition if applicable.

• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures.

Qualifications:

Required:

• Recent BS or MS in Mechanical Engineering Biomedical Engineering or equivalent required.

• Proficiency utilizing the MS Office Suite (Word Excel PowerPoint etc.).

• Good communication and interaction skills with the ability to interface with Health Care Professionals and/or teams across the organization.

• Hands-on engineer.

Preferred:

• Experience with CAD software (Pro-E Creo Solidworks etc).

• Experience in the design and development of mechanical products gained through college co-op internship or research.

• Experience with machining of metals or exposure to a machine shop environment.

• Knowledge of biomechanics biology anatomy is a plus.

• Knowledge of medical device regulations including GMP (Good Manufacturing Practices) QSR (Quality Systems Regulations) and ISO (International Organization for Standardization) quality requirements.

• Knowledge of various types of manufacturing (especially machining) mechanisms materials proper tolerancing drafting standards and an understanding of geometric dimensioning and tolerancing (GD&T).

• Demonstrated creative design ability.

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 internal employees contact AskGS to be directed to your accommodation resource.

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