Product Development Engineer

Johnson & Johnson Innovative Medicine • West Chester, PA

3d • $64,000 - $102,350 • Hybrid

About The 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. This role is for the Orthopaedics division, which is developing the next generation of smarter, less invasive, more personalized treatments. The Orthopaedics teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Requirements

• Recent BS or MS in Mechanical Engineering, Biomedical Engineering, or equivalent required.
• Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint, etc.).
• Good communication and interaction skills, with the ability to interface with Health Care Professionals and/or teams across the organization.
• "Hands-on" engineer.

Nice To Haves

• Experience with CAD software (Pro-E, Creo, Solidworks, etc).
• Experience in the design and development of mechanical products, gained through college co-op, internship or research.
• Experience with machining of metals or exposure to a machine shop environment.
• Knowledge of biomechanics, biology, anatomy is a plus.
• Knowledge of medical device regulations, including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO (International Organization for Standardization) quality requirements.
• Knowledge of various types of manufacturing (especially machining), mechanisms, materials, proper tolerancing, drafting standards, and an understanding of geometric dimensioning and tolerancing (GD&T).
• Demonstrated creative design ability.

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.
• 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.

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 period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level