Staff Mechanical Engineer

at  Vital Biosciences Inc

ABOUT YOU:

You are a highly experienced mechanical engineer with a strong background in the development of complex medical devices, specifically in In Vitro Diagnostics (IVD). You excel in taking products from concept through to validation, focusing on both technical solutions and streamlined documentation in a startup environment. You are creative, resourceful, and capable of balancing regulatory requirements with the need for agility in a fast-paced environment. You thrive on solving challenging problems, mentoring junior engineers, and collaborating across cross-functional teams.

• Contribute to the mechanical engineering design and development of IVD devices from concept through to phase 3, including verification and validation (V&V);
• Collaborate with cross-functional teams to integrate mechanical designs with electrical, software, and systems engineering requirements;
• Optimize designs for manufacturability, cost, and performance while ensuring compliance with regulatory standards (ISO 13485, FDA 21 CFR Part 820);
• Conduct risk analysis (e.g., FMEA) and ensure risk management documentation is maintained and traceable through the design process;
• Support V&V activities, including the development of test protocols, test execution, and data analysis;
• Provide technical leadership in the transfer of devices from design to manufacturing;
• Mentor and guide junior engineers and technicians on design best practices, problem-solving techniques, technical troubleshooting, and documentation;
• Ensure the maintenance of accurate and compliant design documentation, including the design history file (DHF) and associated engineering documentation;
• Contribute to continuous improvement efforts for both the engineering design process and the quality management system (QMS);
• Present design reviews and technical updates to both internal teams and external stakeholders.