Hands-On Biomechanical Engineer – Orthopedics/MedTech

Johnson & Johnson Co.; West Chester (Chester County); Presencial; USD 78 000 - 127 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Vacation 120 hours per year

Sick time 40 hours per year (varies by

Holiday pay 13 days per year

Parental Leave 480 hours per year

Bereavement Leave 240 hours per year

Volunteer Leave 32 hours per year

Military Spouse Time-Off 80 hours per年

Resumo da oferta

Johnson & Johnson in West Chester, PA is recruiting an Engineer, Biomechanical Engineering for DePuy Synthes to lead design and development of implants and instrumentation within a cross-functional team. This role supports regulatory processes and production documentation in a fast-paced medical device environment.

The position requires a BS in Mechanical/Biomedical Engineering with 2–6 years of medical device experience, CAD proficiency, GD&T, FEA, and strong communication skills.

Qualificações

• BS in Mechanical Engineering, Biomedical Engineering, or equivalent required. A Master’s degree is preferred
• 2 to 6 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
• “Hands-on” engineer
• 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

Responsabilidades

• 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

Conhecimentos

CAD proficiency

GD&T

FEA

Regulatory knowledge (MDR/FDA)

Project management

Strong communication

Formação académica

BS in Mechanical Engineering or Biomedical Engineering

Master’s degree preferred

Ferramentas

Pro-E/Creo/SolidWorks

Descrição da oferta de emprego

Johnson & Johnson in West Chester, PA is recruiting an Engineer, Biomechanical Engineering for DePuy Synthes to lead design and development of implants and instrumentation within a cross-functional team. This role supports regulatory processes and production documentation in a fast-paced medical device environment.

The position requires a BS in Mechanical/Biomedical Engineering with 2–6 years of medical device experience, CAD proficiency, GD&T, FEA, and strong communication skills.