R&D Engineer

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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 R&D Engineer located 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 the functional requirement.

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• 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, quality, supply chain, manufacturing, regulatory etc.).
• Interacts 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.
• Develop layouts and tolerance studies utilizing geometric dimensioning and tolerancing (GD&T), and will participate in performing design evaluations (such as FEA, simulated use testing, dry labs and wet tissue/cadaver labs etc.).
• Solve design problems utilizing CAD techniques, rapid and conventional prototyping and other available technologies.
• 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 at suppliers to optimize designs for manufacturability and assembly to produce functioning prototypes and supporting production documentation.
• Assists design and execute mechanical tests, present data and conclusions with appropriate analysis and write technical reports.
• Determines and develops approaches to solutions with technical guidance on the most unusual or complex problems by using six sigma methodologies.
• Knowledge of existing product lines and detailed knowledge of applicable anatomic injuries/pathologies as well as treatment options
• Primarily execute technical tasks.
• Understands and follows the New Product Development process accurately and maintains high quality design validation and verifications.
• Works directly with Health Care Professionals for design concept development, prototype and wet tissue/cadaver evaluation, and clinical follow-up.
• Maintains awareness of surgical trends through involvement with or support of AO Expert Groups/Task forces.
• Engage Health Care Professionals to define user needs and design inputs.
• 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.
• Will be responsible for initial patent review of designs for freedom to operate.
• May be responsible for operating within a budget.
• Support operations projects associated with cost improvement projects and production transfers.
• Performs other special projects and functions as assigned.
• now 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.
• Promotes and nurtures the highest standards of professionalism, ethics and compliance, and actively support our code of business conduct, compliance program-related initiatives and activities.
• Support/Perform quality/compliance activities in support of audits, remediation projects, non-conformances, regulatory compliance projects.
• Participate/Perform complaint investigations and field investigation activities in support of patient/customer safety.

Education:

• A minimum of a Bachelor's degree in Engineering or related discipline is required. Mechanical Engineering degree or demonstrated mechanics focus is preferred.

Required Skills & Experience:

• A minimum of 2 years of experience in the design and development of medical devices, mechanical products, or biomechanical systems
• Mechanical experience (construction, production), min. 1,5 - 2 years as Associate Development Engineer design control experience in mechanical products
• Demonstrated understanding of various types of creative design ability, manufacturing (especially machining), mechanisms, materials, proper tolerancing, drafting standards, and an understanding of geometric dimensioning and tolerancing (GD&T)
• Demonstrates strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience
• 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
• Good communication skills - The ability to effectively communicate concepts, ideas and knowledge to upper management, other individuals, customers, e.g. Health Care Professionals and/ or teams across the organization
• Proficiency utilizing the MS Office Suite (Word, Excel and PowerPoint)
• Ability to work with wet tissues/cadaver and within an Operating Room setting

Preferred Skills & Experience:

• Knowledge of biomechanics, biology, anatomy
• Basic knowledge of orthopaedic/TECA portfolio
• Knowledge of MDR/FDA (510(k) submissions) process and regulation controls, and/or IDE clinical studies
• Knowledge of CAD software (e.g. ProE/ Creo)
• Green Belt in Six Sigma Methodology
• Strong design quality experience with a proven track record in design verification/validation, process verification/validation, and design/process failure modes and effects analyses
• Prior experience working with implantable medical devices
• Experience with plastic injection molding product and/or design-for-manufacturing
• Prior project management experience
• Experience working in medical device regulations, including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO (International Organization for Standardization) quality requirements
• Experience of GDP (Good Documentation Practice)

Other:

• This position is based in West Chester, PA, and requires up to 10% travel

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 and 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, please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.