Research & 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.

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 ones 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:

• Masters degree in Mechanical Engineering Biomedical Engineering or equivalent
• Experience working in medical device regulations including GMP (Good Manufacturing Practices) QSR (Quality Systems Regulations) and ISO (International Organization for Standardization) quality requirements
• The ability to review and critically assess patents and other forms of intellectual property
• Excellent technical writing and communication skills
• Proficient in sample size calculation and statistical methods for analyzing data

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 & 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. Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

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 accommodation please contact us via or contact AskGS to be directed to your accommodation resource.

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Required Skills:

Preferred Skills:

Bioinformatics Biological Engineering Biological Sciences Biostatistics Data Reporting Data Savvy Design of Experiments (DOE) Detail-Oriented Execution Focus Feasibility Studies Preclinical Research Problem Solving Process Oriented Prototyping Report Writing Research and Development Researching SAP Product Lifecycle Management Technologically Savvy

The anticipated base pay range for this position is :

$76000.00 - $121900.00

Additional Description for Pay Transparency:

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: - Experience:

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