Staff Mechanical Engineer

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. What you'll do: 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. What you'll need: Bachelor's or Master's degree in Mechanical Engineering or a related field; 10+ years of experience in mechanical engineering, with significant experience in the medical device industry, ideally in IVD development; Extensive experience with CAD software (SolidWorks preferred) for mechanical design, modeling, and simulation; Strong understanding of product development processes for medical devices, including design controls, V&V, and risk management; Familiarity with manufacturing processes, including CNC machining, injection molding, and additive manufacturing; Proven track record of taking devices through various stages of development, from concept to V&V and clinical trial support; Knowledge of regulatory requirements, including ISO 13485, FDA 21 CFR Part 820, and related medical device standards; Excellent problem-solving skills, with the ability to balance technical, regulatory, and business considerations; Strong communication skills, both written and verbal, with attention to detail. Bonus points for: Experience in design for manufacturing (DFM) and design for assembly (DFA); Working knowledge of Agile or lean product development methodologies; Experience with FEA (Finite Element Analysis) and thermal or fluid dynamic simulations; Familiarity with startup environments, where resourcefulness and creativity are essential; Experience in supporting devices through clinical trials and regulatory submissions.