Research & Development Engineer

Biopharma Asia; Chester (Delaware County); Hybrid; USD 76,000 - 122,000; Full time

Benefits offered by this job

Vacation time

Sick leave

Holidays

Parental leave

Bereavement leave

Volunteer leave

Military spousal leave

Job summary

Biopharma Careers is seeking a Research & Development Engineer for our Orthopaedics team in West Chester, PA. This hybrid role blends design work with cross‑functional collaboration to develop next‑gen implants and instrumentation.

The engineer will lead design activities, perform GD&T analyses, conduct CAD-based prototyping, and support regulatory submissions. A BS in engineering with 2–6 years of medical devices experience is required, with a master’s preferred.

Qualifications

• BS in Mechanical or Biomedical Engineering or equivalent.
• 2–6 years in medical devices design and development.
• Hands-on engineering experience in a regulated field.
• Experience with CAD software and GD&T.
• Ability to work in operating rooms with wet tissues/cadavers.

Responsibilities

• Lead design and development projects with cross‑functional teams.
• Define user needs with clinicians and marketing.
• Develop and evaluate designs using CAD, prototyping, FEA, and testing.
• Create design verification/validation plans and documentation.
• Support MDR/FDA regulatory activities and 510(k)/IDE processes.
• Work with supply chain to optimize manufacturability.

Skills

Hands-on engineering

Communication skills

Problem solving

Interpersonal skills

Education

BS in Mechanical or Biomedical Engineering

Master’s degree (preferred)

Tools

CAD software (Pro/E/Creo/SolidWorks)

Job description

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 related 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
• 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, we’re 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 that’s 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 https://www.jnj.com/medtech

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. 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 plans. In 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 under 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 https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

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

Pay Transparency:

The anticipated base pay range for this position is :

$76,000.00 - $121,900.00

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: - https://www.careers.jnj.com/employee-benefits