Open Positions

The Quality Inspector will be responsible for quality inspection/quality assurance activities. This includes interpretation and implementation of quality standards to routine inspection/testing and manufacturing activities.

Responsible for leading the AI/Automation software development team which focuses on developing and delivering software products for use in digital design of restor3d patient specific implants and instruments. Specific job duties include: •Leading the development and implementation of the Artificial Intelligence/Automation software engineering development team strategy in alignment with the business objectives for scalable Digital Production of patient specific devices and distill such strategy into actionable plans; •Directing the Artificial Intelligence and Automation software engineering development and testing team, oversee resourcing, including planning and budgeting; •Conduct and participate in risk management activities per ISO14971 to ensure the safety and effectiveness of software product •Managing software development lifecycle for key products including: Development of detailed software requirements in collaboration with stakeholders such as Digital Production, Process Development, Product Development, Marketing and other internal teams; Management of software development phases per internal procedures in compliance with FDA 21CFR 820.30 Design Controls and IEC 62304 standards; Conduct and moderate all formal design reviews (e.g. scope, software requirements, design history file documents per design controls, verification and validation strategy, test reports etc.); Collaboration on testing and validation plan(s) and execution for automation projects; Management of software deployment, including bug tracking and resolution; Collaboration with Regulatory and Clinical as required by product scope. •Responsible for Risk Management, Design Inputs review, Design History File Documents review, Design Output Document review, test plans, software verification and validation strategies. •Evaluation and management of third-party development firms, vendors, or other external entities as it pertains to software engineering development team’s work; •Leading software engineering integration efforts, including workflow integration, quality system/documentation standardization for software development lifecycle, and consolidation of software platforms, tools, and documents; •Assisting leadership in optimizing the scope, benefits, and risks of proposed engineering products; •Interfacing with cross-functional engineering teams for quarterly business unit reviews. Requirements: Position requires either a Bachelor’s degree (or an equivalent foreign degree) in Computer Science, IT, Engineering Management or a closely related field and 5 years of experience as a Systems Engineer or a Master’s degree (or an equivalent foreign degree) in Computer Science, IT, Engineering Management or a closely related field and 3 years of experience as a Systems Engineer. Must also have 3 years of experience (which can have been gained concurrently with either of the primary experience requirements above) working with the following: • Authoring regulatory and quality system documentation; • Developing and maintaining documentation for traceability, design controls, and verification & validation (V&V) activities as required for regulatory compliance per ISO 13485 and FDA 21CFR 820.30 Design Controls; • Medical Device Software Development Life Cycle Process (SDLC) and IEC 62304; • New product development process and various phases of new product development; • Executing risk management practices per ISO 14971 and IEC 62304; • Basic programming (CL, RPG, COBOL, Synon2E, C, C++ or similar) and tools for configuration management (Aldon or similar). • Unit and System level testing and root cause analysis and defect resolution This is a hybrid position working 1 day/week at the company’s office in Durham, NC and 4 days/week working at a home office.

The Warehouse Coordinator will be responsible for conducting various materials or inventory control functions in support of the company’s production and customer requirements, including, but not limited to, shipping, receiving, proper warehousing of materials, and inventory management. Shift: Onsite M-F, 9:30am to 6pm

The Additive Manufacturing Technician will be responsible for the manufacturing, inspection, and final product packaging and sterilization of restor3d implants and components. We have available positions on both first and second shift. 1st Shift – Mon – Fri, 7:00am – 3:30pm 2nd Shift – Mon – Fri, 3:00pm – 11:30pm

We are seeking a customer-oriented, highly skilled, and experienced Desktop Support Analyst to join our IT team and provide onsite support and maintenance for desktop systems and software. This role requires an understanding of operating systems (Windows, macOS), hardware, software, security, and networking.

The Manufacturing Technician position is responsible for operating production equipment in a productive manner while maintaining a high level of quality in the manufacturing of restor3d implants and components. 1st Shift – Mon – Fri, 7:00am – 3:30pm 2nd Shift – Monday – Fri, 3:30 pm – 11:30 pm

The Material Control Coordinator will be responsible for various tasks related to inventory control, receiving, storage, kitting and distribution of materials to support our operations. This position requires strong attention to detail, excellent organizational skills, and the ability to work effectively in a fast-paced environment. Shift: 11:00 AM – 7:00 PM

The Production Control Coordinator will be responsible for coordinating and expediting the flow of work and materials within and between departments according to the production schedule. Duties include reviewing and distributing production, work, and shipment schedules, conferring with the department leads to determine progress of work and completion dates, and compiling reports on progress of work, inventory levels, and production issues.

The Quality Inspector will be responsible for quality inspection/quality assurance activities. This includes interpretation and implementation of quality standards to routine inspection/testing and manufacturing activities. Shift: 7am to 3:30pm

The Quality Engineer will be responsible for assisting in the development, implementation, and oversight of the quality system of the company while providing support to operations/manufacturing, manufacturing engineering, and product development.