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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 OrthopaedicsFueled 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 ;br>
DePuy Synthes is recruiting for a Engineer, Biomechanical Engineering to be based in West Chester, PA
Purpose:Helps 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.
Job Responsibilities: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.
- 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/Requirements:- BS in Mechanical Engineering, Biomedical Engineering, or equivalent required. A Master's degree is preferred
- Minimum 2 + years of experience in the design and development of medical devices, mechanical products, or biomechanical systems is required.
- Experience with CAD software (Pro-E, Creo, Solidworks, etc.) is required.
- Understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and GD&T are required.
- Experience working in medical device regulations, including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO (International Organization for Standardization) quality requirements is preferred.
- Demonstrated success in bringing product 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 is all required.
- Demonstrated creative design ability.
- Demonstrated ability to prioritize tasks and manage a varied workload
- Prior project management experience preferred.
- The ability to review and critically assess patents and other forms of intellectual property is preferred.
- Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint, etc.) is required.
- Ability to work with wet tissues/cadaver and within an Operating Room setting is required.
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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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 :$76,000.00 - $121,900.00
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.
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: -
