Product Development Engineer

Brighter Signals; West Chester (Chester County); Hybrid; USD 64,000 - 102,000; Full time

Benefits offered by this job

Vacation 120 hours per year

Sick time 40 hours per year

Holiday pay

Job summary

Johnson & Johnson is seeking a Product Development Engineer to join the Orthopaedics team in West Chester, PA, operating in a hybrid role. The engineer will design and develop medical devices across the product lifecycle, collaborating with cross‑functional teams to translate clinical needs into manufacturable solutions.

Responsibilities include leading design activities, conducting verifications, ensuring MDR/510(k) compliance, and supporting manufacturing for scalable production.

Qualifications

• 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.

Responsibilities

• Lead design and development projects with oversight and coordinate with core team.
• Define user needs and design inputs with Health Care Professionals.
• Solve design problems using CAD, prototyping, and related technologies.
• Develop layouts and tolerance studies (GD&T) and participate in design evaluations (FEA, testing).
• Develop verification/validation plans and support regulatory processes for submissions.

Skills

MS Office Suite

Communication skills

Hands‑on engineer

Education

BS or MS in Mechanical/Biomedical Engineering

Tools

CAD software (Pro‑E/Creo/Solidworks)

Job description

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

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

We 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 one's 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

• 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 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 an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$64,000.00 - $102,350.00

Additional Description For Pay Transparency

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company’s long-term incentive program.

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