Senior Device Development Engineer

Summary

Join Dianthus Therapeutics as a Senior Device Development Engineer and become the design and development engineering expert for pre-filled syringes, directly impacting user experience, product quality, and reliability. Lead and oversee the development of the Accessorized Pre-filled Syringe (APFS), maintaining the design history file, and working with cross-functional teams and vendors. You will lead design, development, and testing for the APFS and contribute to autoinjector development. This highly visible role significantly impacts bringing novel therapies to patients. Remote work is an option. The company fosters a culture centered on core principles to elevate patient care.

Requirements

• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or a related field
• Minimum of 5–8 years of experience in medical device development, specifically with autoinjectors or pre-filled syringes
• Strong knowledge of design controls, risk management (21 CFR Part 4, ISO 14971, ISO 13485, ISO 11608, ISO 11040 and ISO 23908), and usability engineering principles
• Hands-on experience with mechanical design tools (e.g., SolidWorks, Creo) and simulation software (e.g., FEA tools)
• Proven track record in device testing, including functional testing, reliability analysis, and usability studies
• Familiarity with materials commonly used in drug delivery devices, such as plastics, elastomers, and metals
• Comprehensive understanding of relevant regulatory requirements (FDA, ISO 11608, EMA)
• Design History File (DHF) experience

Responsibilities

• Lead the design and development of autoinjectors, pre-filled syringes, and other parenteral drug delivery devices
• Ensure that selection of materials, components and service providers results in a robust product design
• Work closely with cross-functional teams, including mechanical engineering, materials science, and regulatory affairs, to ensure designs meet user needs and regulatory standards
• Develop and validate prototypes through rigorous testing and analysis
• Conduct design verification and validation (V&V) studies, including performance testing, functional evaluations, and reliability analysis
• Oversee project timelines, budgets, and deliverables to ensure successful device development
• Collaborate with stakeholders to prioritize project goals and address technical challenges
• Prepare and review technical documentation, including design history files, risk assessments, and usability engineering reports, in compliance with ISO 13485, ISO 11608, and FDA guidelines
• Support regulatory submissions by providing technical expertise and data
• Partner with external suppliers to source components and ensure manufacturability
• Assist in technology transfer to manufacturing teams, including process optimization and troubleshooting

Benefits

We are open to you working remotely