Lead Product Engineer

The Lead Product Engineer role will be responsible for executing the main elements of Design, from concept through Product Transfer and ongoing sustaining activities, for orthopedic implants and surgical instruments related to design changes.

• Design and develop new products and related assembly and manufacturing processes, including final packaging. These processes range from raw material processing to final device assembly. Provide technical leadership for all new product projects and sustaining R&D activities.
• Responsible for all technical stage/gate deliverables for new product development.
• Translate the voice of the customer needs into target product solutions, concepts, and new product proposals.
• Prototype and develop proof of concept designs, disease models, and test methods of testing these concepts in a simulated environment and develop new product designs based on the defined user needs, traceability matrix and verification and validation activities.
• Work within a regulated medical device environment, ensuring all programs and documentation meet rigorous quality standards and regulatory guidelines, such as FDA and ISO requirements.
• Lead and participate in design reviews, contributing to the continuous improvement of our processes & monitor key performance indicators (KPIs).
• Collaborate with Surgeon, Customer Service, Management, Engineering, and machine operators on new product launches, continuous improvement activities to ensure designs are manufacturable and to troubleshoot any issues.
• Create and maintain product CAD, including assemblies, components, and detailed drawings.
• Primary support for PFR creation, managing case priority according to need date and PFR accuracy and surgeon approvals, and associated documentation.
• Review and edit reconstructed CT imaging using software such as Materialize Mimics to create 3D CAD models of bony anatomy
• Review and edit the PFR knee implant component 3D models using CAD software
• Review and approve bone models, final implant and associated documentation.

• Medical device experience:
  Previous experience with FDA or EU Regulatory audits is desired.
• Lean or Six Sigma certification is desired.
• Knowledge of CAM/CNC programming or automation systems.
• Highly efficient in Solid Works and PDM.

• Bachelor’s degree in engineering or technical area and 5 years minimum of heavy Product Development and/or CAD/CAM experience in a medical device or highly regulated environment.
• Solid understanding of anatomy and bone terminology, Industrial Design and Human Factors and applying specific knowledge of implant design principles, biocompatible materials, and surgical requirements.

Accommodation for applicants with disabilities is available upon request.

TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.