Job Description
Owen Mumford are looking to hire an enthusiastic Senior Device Technologist! Could this be your next role?
Scope:
As the Senior Device Technologist you will join the R&D department to provide technical leadership in device testing, evaluation, and stability assessment of medical devices, including drug delivery devices including auto-injectors, pen injectors, pen needles, and lancing devices. The role combines hands-on technical expertise with project leadership and client-facing responsibilities.
Key Responsibilities:
1. Work closely with the Device Design Engineers to establish the test matrices for Medical devices in R&D.
2. Define and execute device testing strategies, including functional testing, usability, robustness, and stability studies for the different devices coming through R&D.
3. Oversee verification and validation activities in accordance with ISO 13485 and FDA/EMA expectations.
4. Interpret and report data from device testing and stability programs.
5. Support regulatory submissions with technical documentation and justifications.
6. Act as technical lead on client projects, providing expert guidance and problem-solving.
7. Mentor junior device technologists and review technical work.
8. Provide technical input into design controls, risk management (ISO 14971), and usabil...