✨ About The Role
- The Mechanical Engineer will lead the design and development of mechanical components for an at-home blood testing platform.
- The role involves applying design control processes to ensure compliance with regulatory standards throughout the product lifecycle.
- Conducting FMEA to assess and mitigate risks in product design is a key responsibility.
- The engineer will implement Design for Manufacturability (DFM) principles to ensure efficient production.
- Collaboration with cross-functional teams, including engineering, regulatory, and manufacturing, is essential for seamless development.
âš¡ Requirements
- The ideal candidate will have a strong background in mechanical engineering, particularly in the biotechnology or medical device sectors.
- A minimum of 5 years of experience in mechanical design is essential, with a focus on instrumentation.
- Proven experience with design controls and development processes for regulated products is crucial for success in this role.
- The candidate should possess hands-on experience with Failure Modes and Effects Analysis (FMEA) and risk management in product design.
- Strong communication and collaboration skills are necessary to work effectively across multiple teams.