WOVEN ORTHOPEDIC TECHNOLOGIES, LLC. OVERVIEW:
Woven Orthopedic Technologies is a healthcare company that leverages advances in smart engineered bio-textiles to improve patient care. Our premier technology addresses poor screw engagement, the #1 problem in the $6.5B internal fixation market that results in delayed recovery, additional treatment, and potential secondary surgeries (revisions).
Unlike current technologies that focus on solving loss of screw engagement by improving the hardware, (expandable screw, rescue screws, etc) we have developed a unique bio-textile that targets the source of the problem by improving the bone-to-screw interface (the “hole” in the bone).
Woven Orthopedic Technologies is a Viscogliosi Brothers, LLC (“VB”) portfolio company. VB was the first firm dedicated exclusively to the neuro-musculoskeletal industry and has exited more than 10 companies including its 2 most recent exits, the sale of Small Bone Innovations to Stryker Corp and the sale of Knee Creations, LLC to Zimmer Holdings, Inc.
The Senior Product Development Engineer will serve as a technical lead/project engineer for multiple simultaneous development projects related to Woven's primary device system. The Senior Product Development Engineer will ensure that engineering design activities are aligned with the company's goals and work closely with the internal and contracted R&D team to accomplish design and development objectives.
The Sr. Product Development Engineer will be responsible for leading, participating in, or supporting the concept, planning, design, and execution of major new prodicts or product enhancements including leading all prototyping / testing, pilot production, risk assessments, design reviews, verification & validation, and pre-production initiatives.
The Sr. Product Development Engineer can expect to:
- Assist in project planning and provide technical team leadership in project execution
- Create and release Product Requirements
- Design Specifications and Design Descriptions for assigned projects, as required by applicable medical device standards and internal procedures
- Research design options and perform experiments to determine potential design feasibility
- Interact with global and internal design and manufacturing resources to design for manufacturability, reliability and cost-effectiveness
- Review product documentation for accuracy including documentation intended for customer use
- Evaluate product non-conformances and recommend design modifications
- A Bachelor's degree in Mechanical Engineering or Biomedical Engineering, other related Engineering disciplines will be considered
- 5+ years of relevant experience in mechanical product development / design
- Prior experience with medical device development
- Experience in orthopedics, especially Class II/III implant systems and related devices strongly preferred.
- Knowledge of relevant manufacturing processes and materials
- Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Project
- Knowledge of Anatomy, Physiology, and Biomechanics is preferred
- Experience working within Quality System Regulation (QSR) / current Good Manufacturing Process (GMPs)