Senior Device Development Engineer - Autoinjector

Posted 14 days agoViewed

💎 Seniority level: Senior, 5–8 years

📍 Location: USA

🔍 Industry: Biotechnology

🏢 Company: Dianthus Therapeutics👥 11-50💰 $230,000,000 Post-IPO Equity about 1 year agoBiotechnology Biopharma Health Care

⏳ Experience: 5–8 years

🪄 Skills: Project ManagementProduct designComplianceQuality AssuranceRisk ManagementPrototyping

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, and usability engineering principles.
Hands-on experience with mechanical design tools and simulation software.
Proven track record in device testing and analysis.
Familiarity with materials used in drug delivery devices.
Comprehensive understanding of relevant regulatory requirements.
Design History File experience.

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 to ensure designs meet user needs and regulatory standards.
Develop and validate prototypes through rigorous testing and analysis.
Conduct design verification and validation studies.
Oversee project timelines, budgets, and deliverables.
Prepare and review technical documentation in compliance with regulations.
Partner with external suppliers to source components.