A Manufacturing Process Engineer develops workflow, work station, and equipment improvement recommendations within a company's manufacturing environment. Fine tunes manufacturing processes by researching, designing, modifying, and testing manufacturing methods and equipment. Evaluates manufacturing processes, applies knowledge of product design, fabrication, assembly, tooling, and material.
Job Brief 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. All positions at Astura report to the office daily and we do not have remote or hybrid opportunities currently. Normal work hours are from 8 am to 5 pm. Responsibilities 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.
Requirements:
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.
