Transducer Engineer

Merz Pharmaceuticals USA Mesa , AZ 85205

Posted 5 months ago

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 design for manufacturing, from feasibility through transfer to production
  • Required
  • Experience building prototypes in an R&D environment
  • Required
  • Familiarity with transducer characterization (impedance, acoustic tank, pulse-echo, force balance, transmitting voltage response)
  • Preferred
  • Medical ultrasound transducers
  • Preferred
  • Materials design and testing
  • Preferred
  • Familiarity with acoustic standards (IEC 60601-2-62, IEC 60601-2-37, 21CFR1050.10, MIL-STD-1376)
  • Preferred
  • SolidWorks
  • Preferred
  • Finite Element Analysis (FEA)
  • Preferred

KNOWLEDGE OF METHODS:

  • Product Development Process
  • Required
  • Good Manufacturing Practices
  • Preferred

PERSONAL SKILLS:

  • Effective interpersonal skills enabling constructive communication with cross functional groups
  • Required

EDUCATIONAL BACKGROUND:

  • BS, Mechanical, Electrical, Biomedical Engineering or BS, Physics, Materials Science
  • Required
  • MS, Mechanical, Electrical, Biomedical Engineering or MS, Physics, Materials Science
  • Preferred
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Transducer Engineer

Merz Pharmaceuticals USA