> Markdown version of [/jobs/ext/265410-sr-design-engineer](https://www.wearedevelopers.com/jobs/ext/265410-sr-design-engineer). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Sr. Design Engineer - **Company:** Astura Medical - **Location:** Irving, TX, United States - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** 3d Models, Verification and Validation (Software) - **Published:** May 17, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=d740f2aa32626db5 ## About the Role Do you have experience in Task prioritization?, We are seeking an experienced Sr. Design Engineer to provide leadership support to our Spinal Hardware Products team within the R&D department. The Senior Design Engineer will be responsible for the design, development, verification and validation of new and existing products for our spinal hardware portfolio. This role requires a strong technical background in mechanical engineering, desire to grow in leadership and the ability to collaborate effectively across teams. The Sr. Design Engineer will play a pivotal role in driving innovation, ensuring product quality, and meeting regulatory requirements in the spinal medical device sector., * Minimum B.S. degree in Mechanical Engineering, Biomedical Engineering, or related field. * Minimum 5 years of experience in engineering roles within the medical device industry. * Strong background in medical device product development, including design, testing, and manufacturing processes. * Knowledge of materials selection, manufacturing processes (e.g., machining, casting), and product lifecycle management. * Experience in analytical processes (e.g., FEA, numerical modeling, Risk Analysis). * Experience with contract manufacturer development and working relationships. * Experience with implantable medical devices or surgical instrumentation. * Familiarity with design for manufacturability (DFM) and design for assembly (DFA) principles. * Excellent organizational and communication skills. * Ability to prioritize tasks and manage multiple projects effectively. * Hands-on, driven work ethic. Authorization to Work in the U.S.: Candidates must be legally authorized to work in the United States without sponsorship now or in the future. Astura Medical is not currently sponsoring visas, including, but not limited to, H-1B, TN, or EAD, and we are not accepting visa transfers. Physical Requirements This is largely a sedentary role; prolonged periods sitting at a desk and working on a computer. This would require the ability to lift files, open filing cabinets and bend or stand as necessary. ## Description * Primary leader of assigned product development and sustaining projects. * Collaborate with cross-functional teams including R&D, Quality Assurance, Manufacturing, and Regulatory Affairs to achieve project goals and timelines. * Execute on the design, development, verification, and validation of new products, ensuring alignment with market needs and regulatory requirements. * Execute detailed mechanical component and assembly CAD models. * Generate detailed product drawings and component specifications. * Manage design transfer activities from R&D to manufacturing, optimizing processes and ensuring scalability. * Manage and prioritize sustaining engineering efforts for existing products, addressing design improvements, and manufacturing optimizations. * Implement corrective actions and continuous improvement initiatives based on post-market feedback and quality data. * Ensure compliance with FDA regulations (e.g., 21 CFR Part 820) for medical devices. * Collaborate with Regulatory Affairs to support regulatory submissions. * Evaluate and recommend technologies, tools, and resources necessary for product development and sustaining activities. ## Related Videos - [Valven Atlas: Engineering Intelligence That Delivers](https://www.wearedevelopers.com/videos/1660-valven-atlas-engineering-intelligence-that-delivers) - [Times of (climate) crisis - How and why sustainable software is a must!](https://www.wearedevelopers.com/videos/988-times-of-climate-crisis-how-and-why-sustainable-software-is-a-must) - [TresJS a new declarative ThreeJS as Vue components](https://www.wearedevelopers.com/videos/543-tresjs-a-new-declarative-threejs-as-vue-components) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [Kettle and Pot or Peas in a Pod? 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