• Lead product development activities by coordinating internal departments and external vendors to meet project deadlines.• Develop systems of orthopedic spinal implants, instruments, and sequentially ordered trays to provide orthopedic surgeons an entire surgical solution.• Communicate with physicians, surgeons, and sales representatives to determine design solutions.• Rapid prototype and refine designs using a variety of fabrication techniques.• Develop and implement both short-term and long-term solutions for product improvements.• Carry out product validation/verification activities; developing test criteria and writing test protocols/reports.• Create manufacturing documentation (drawings, material specifications, inspection procedures, and manufacturing instructions).• Serve as a primary member of the Material Review Board (MRB) to address non-conformance related activities.

• Lead product development activities by coordinating internal departments and external contacts to meet project deadlines.• Create manufacturing documentation (drawings, material specifications, inspection procedures, product labels, and manufacturing instructions).• Validate ETO sterilization processes and packaging systems for all company products.• Generate product specification and failure mode effects analysis documentation.• Strategically identify, filter, and resolve issues to meet project requirements and corporate goals.• Work with vendors to research and acquire materials, components, and product tooling.• Perform all equipment calibration and maintenance activities and maintain records.• Plan, execute, and maintain corporate activities to meet FDA GUDID compliance.• Develop test criteria and protocols; review results with statistical analysis and write test reports.• Perform validation and verification activities.• Provide technical input for all documentation changes.• Perform investigations of product complaints.• Handle all non-conformance investigations and resolutions.• Organize document change activities and maintained records.• Work with distributors to analyze feedback and perform product changes/notifications.

Product Development and Design – Worked on early stage product development, including competitive product testing and prototype testing. Developed both short-term and long-term solutions for product improvements. Designed fixtures and tooling to evaluate designs and manufacture products.Process Development – Created and validated product manufacturing methods and process test methods. Created manufacturing documentation including drawings, material specifications, inspection procedures, and manufacturing instructions. Understood and met internal quality control and regulatory requirements. Adhered to regulations and procedures to meet FDA and UL requirements.Project Management – Compiled Design History Files. Developed project timelines. Coordinated multidisciplinary teams to meet product timelines. Determined test requirements and methods through the creation of testing protocols and analytical testing reports. Trained production teams and technicians on proper manufacturing processes and the correct use of various equipment.External Duties – Communicated with surgeons and sales representatives to determine design solutions. Observed surgical cases in hospitals and offering technical support to sales teams and surgeons. Interacted with suppliers and vendors to research and acquire materials and tooling.

Software Testing – Tested various software programs being developed for military application based on defined test cases and ad-hoc testing. Identified, documented, and reported problems in the software. Worked directly with developers to create solutions to software problems.