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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:
We are searching for the best talent for a Senior Research and Development Engineer, to join our Orthopaedics team. This is a hybrid role located in West Chester, PA.
Purpose:
The Senior R&D Engineer will be responsible for the design and development aspects of complex systems and projects, technically leading cross-functional project teams through all phases of the product life-cycle, and will often organize, plan, execute and oversee projects through product launch, commercialization, and post market surveillance.
In this role, you will design and develop new implants and instrumentation and/or support in-market products through their product life-cycle within multiple cross-functional project teams. This includes communication with customers, e.g., Health Care Professionals, marketing and sales consultants, understanding of clinical issues, defining the design parameters, and ensuring the product which is provided to the customer meets the functional requirements. Furthermore, the Senior R&D Engineer will be an integral resource to the R&D team, as a leader and mentor for associate R&D engineers and R&D engineers.
Key Responsibilities:
- Act as a technical team leader and in some cases project leader as a member of a cross-functional project core team (marketing, manufacturing, quality, testing, supply chain, regulatory, etc.).
- Coordinates with design engineers, marketing, quality, supply chain, manufacturing, regulatory affairs. Health Care Professionals, and other functional departments to define and develop product requirements and concepts on new or existing products.
- Solve complex design problems utilizing CAD techniques, rapid and conventional prototyping, and other available technologies. Generate design concepts and prototypes independently.
- Perform design evaluations (such as tolerance analysis, GD&T, FEA, simulated use testing, dry labs and wet tissue/cadaver labs etc.) Document clinical and surgical technique observations to create meaningful design solutions.
- Development and execution of design verification and validation plans and activities, and test plan formation and execution to support global regulatory strategy.
- 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.
- Drive initial patent review and freedom to operate activities from concept to launch.
- Collaborate with supply chain, manufacturing engineering and/or suppliers to optimize designs for manufacturability and assembly to produce functioning prototypes and support production documentation.
- Designs and executes or coordinates mechanical tests and scientific experiments, present data and conclusions with appropriate analysis and write technical reports.
- Independently determines and develops approaches to solutions with technical guidance on the most unusual or complex problems by using six sigma methodologies.
- 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.
- Act as a subject matter expert on existing product lines and detailed knowledge of applicable anatomic pathologies as well as treatment options.
- Works directly with Health Care Professionals, and other functional departments to define and develop product requirements and design concepts/prototypes on new/or existing as well as wet tissue/cadaver evaluation, and clinical follow-up.
- Understands and follows the New Product Development process accurately and maintains high quality design validation and verifications.
- Recognized as a leader on projects and assignments.
- Act as a mentor for interns / Co-Op's.
- May be responsible for operating within a budget and provide input on budget allocation and prioritization.
- Carries out smaller projects of limited complexity and scope under general supervision.
- Perform complaint investigations and field investigation activities in support of patient/customer safety.
- Perform quality/compliance activities in support of audits, remediation projects, non-conformances, regulatory compliance projects.
- 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.
Required Qualifications:
- BS in Mechanical Engineering, Biomedical Engineering, or equivalent.
- Minimum of six years of experience in the design and development of medical devices, mechanical products, or biomechanical systems, including multi-component systems.
- Strong experience with CAD software (Pro-E, Creo, Solidworks, etc.)
- Experience in identifying user needs (VOC), medical device design principles, material selection, ability to verify and validate design concepts, and understanding design failure modes.
- Demonstrated understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and GD&T.
- Strong communication and interaction skills, with the ability to interface with Health Care Professionals and sales/marketing personnel.
- Possess strong organizational skills to support all aspects of the project management functions including scope definition, budgeting, and contingency planning.
- Excellent 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 required.
- Must demonstrate a strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience.
- Demonstrated success in bringing products from design through introduction on time.
- Demonstrated creative design ability.
- Ability to work with wet tissues/cadaver and within an Operating Room setting.
- Must have the ability to effectively communicate concepts, ideas and knowledge to other individuals, Health Care Professionals, customers and/ or teams, and work effectively as a technical leader and sometimes as a project leader.
- Excellent technical writing and communication skills.
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.
- 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 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.
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Required Skills:
Preferred Skills:
Analytical Reasoning, Bioinformatics, Biological Engineering, Biological Sciences, Biostatistics, Coaching, Data Savvy, Detail-Oriented, Feasibility Studies, Inventory Management, Preclinical Research, Project Schedule, Prototyping, Research and Development, Researching, SAP Product Lifecycle Management, Technologically Savvy
The anticipated base pay range for this position is :
$92,000.00 - $148,350.00
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)).
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: - https://www.careers.jnj.com/employee-benefits
