ESSENTIAL DUTIES AND RESPONSIBILITIES
Transducer design: Designs, builds, and tests ultrasound transducers per 21CFR820 using a design for manufacturing approach. Scope includes prototype manufacturing, testing, test plans/protocols and their execution.
Project management: Work with design partners on device design and with Merz project management to identify effort necessary to satisfy objectives. This includes identifying risks and developing contingency plans.
Prototype manufacturing: Lead engineering prototype builds, including generating BOMs, ordering parts and materials, and training lab technicians. Design of transducer manufacturing processes and work with operations group to transfer devices to manufacturing.
Transducer subject matter expert: Provide transducer technical expertise to cross functional groups including operations, regulatory, and clinical teams especially in technical explanation and root cause analysis.
Documentation: Maintain accurate documentation throughout the design process per GDP and GMP.
KNOWLEDGE, SKILLS, AND ABILITIES:
KNOWLEDGE OF METHODS:
Merz Pharmaceuticals USA