Product Design Engineer Engineering, Large Joints

Key Responsibilities

• Provide design, engineering, and analysis support to other engineers and designers in the development and maintenance of orthopedic implants and instruments.
• Apply sound engineering problem-solving techniques to product development and maintenance tasks including design, analysis, material selection, inspection requirements and manufacturing process requirements.
• Prepare and submit written and oral communications that describe product design concepts, attributes and performance and project status. Areas of involvement include regulatory submissions, design history files, device evaluation and testing, manufacturing or supplier support, quality control, packaging, operating room support, device complaint evaluation, patent disclosures and instrument refurbishment.
• Define and execute product testing and validation protocols.
• Establish appropriate project plan (i.e. define tasks, dependencies, schedule and resource requirements).
• Complete and approve all Design History File documentation for assigned projects as required.
• Lead a cross-functional project team (including both internal and external team members such as orthopedic surgeons) of one or several minor development projects. A minor project involves the modification, adaptation or extension of an existing product or product line.
• Study and recommend improvements to existing products and processes. This entails staying “up to date” on emerging material and medical product technologies. This may be accomplished by attending seminars, classes and industry meetings. Contribute to the timely and accurate completion of the projects and tasks assigned to his/her team.
• Know and apply the Quality System and any appropriate Federal and International standards.
• Assist and support other employees, teams, and sales personnel as necessary.