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.

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.

• 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.