Position
As a Senior Product Engineer, you will collaborate with clinicians, researchers, engineers, and quality, commercial, and regulatory teams to advance Zeta’s product portfolio. Your responsibilities will include new product development to expand Zeta’s clinical indications, as well as sustaining engineering to continuously improve the Zeta system based on its performance, company priorities, and user feedback.
Responsibilities
- Contributing to and documenting all aspects of product development including concept, risk analysis, device design and labeling, V&V, change control, design transfer, launch, and post-market surveillance.
- Understanding clinical needs, workflows, environments, and users, such as by observing cases, developing mockups or prototypes, preparing questionnaires, or conducting clinical simulations.
- Staying informed of evolving regulatory and commercial environments.
- Contributing to scientific publications, clinical reports, and regulatory submissions.
Skills
- Demonstrated strong analytical, problem solving, and communication skills.
- Demonstrated ability to balance planning and execution to rapidly iterate on concepts.
- Demonstrated ability to work with technical, commercial, regulatory, and clinical teams.
- Experience developing medical devices, including familiarity with QMS, risk management, international standards, common medical design constraints, and FDA guidance documents.
- Experience with rapid prototyping of both hardware and software, including 3D modeling.
- Experience working on sterile or disposable medical devices is a plus.
- Experience working in surgical navigation or with 3D medical imaging data such as CT or MRI is a plus.
About you
Minimum bachelor’s degree, preferably in a relevant field, such as Biomedical Engineering, Mechanical Engineering, Electrical Engineering or Computer Science.