Product Development Engineer

About This Role

The Product Development 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. This role assists the project leader with planning and executing projects or portions of a project through product launch, commercialization, and post market surveillance. The team focuses on developing smarter, less invasive, more personalized treatments in orthopaedics.

Responsibilities

• Technically lead design and development projects with oversight
• Work closely with the project leader and 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
• Participate in performing design evaluations (such as FEA, simulated use testing, dry labs and wet tissue/cadaver labs etc.)
• Develop and execute design verification/validation plans, test methods and protocols
• Support regulatory processes for global registration efforts
• Perform required activities and generate appropriate documents to ensure compliance with MDR and FDA Design Control regulations
• 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
• Produce functioning prototypes and supporting production documentation
• Demonstrate proficiency in the application of design controls and development processes
• Support the project leader with aspects of the project management functions including scope definition and contingency planning
• Possess knowledge of existing product lines and detailed knowledge of applicable anatomic injuries/pathologies as well as treatment options
• Understand and follow 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, and regulatory compliance projects
• Be responsible for initial patent review of designs for freedom to operate
• Support Operations projects associated with Cost Improvement Projects and Production Transfers
• Perform 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