Research & Development Engineer

6317-Synthes USA Products, LLC Legal Entity; West Chester (Chester County); Hybrid; USD 76,000 - 122,000; Full time

Job summary

Johnson & Johnson is seeking a Research & Development Engineer to join the Orthopaedics team in a hybrid role based in West Chester, PA. You will lead design and development of implants and instrumentation, guiding projects through the product life cycle and interfacing with customers, healthcare professionals and marketing.

The role requires a BS in Mechanical or Biomedical Engineering, 2–6 years of medical device experience, CAD proficiency (Pro/E/Creo/SolidWorks), GD&T knowledge, and strong

Qualifications

• BS in Mechanical or Biomedical Engineering.
• 2–6 years in design and development of medical devices.
• Experience with CAD software (Pro-E/Creo/SolidWorks).
• Familiarity with GD&T and manufacturing processes.
• Ability to work in operating room environment.
• Proven track record delivering products on time.
• Strong communication and teamwork.

Responsibilities

• Technically lead design and development projects.
• Collaborate with cross-functional teams (marketing, manufacturing, quality, etc.).
• Engage Health Care Professionals to define user needs.
• Apply CAD methods, prototyping, and tolerance studies.
• Develop design verification/validation plans and protocols.
• Support regulatory submissions and post-market activities.
• Ensure manufacturability and design for assembly.

Skills

Hands-on engineering

CAD experience

GD&T

Medical devices

Education

BS in Mechanical Engineering

BS in Biomedical Engineering

Tools

Pro/E

Creo

SolidWorks

Job description

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

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.

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

The anticipated base pay range for this position is : $76,000.00 - $121,900.00

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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 https://www.jnj.com/. Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive. Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities. If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you.