Principal Engineer

4 weeks ago

Raleigh, North Carolina, United States Merz North America Inc Full time

The Principal Transducer Engineer will lead ultrasound transducer projects through the product development process from feasibility and prototype building through verification and transfer to production. The engineer will be responsible for transducer design efforts in house as well as managing external design partners. Responsible for providing cross functional technical expertise including operations, regulatory, and clinical groups.

Essential duties and responsibilities
  • Transducer design:
    • Designs, builds, and tests ultrasound transducers per 21CFR820 using a design for manufacturing approach. Scope includes simulations, fabrication, testing as well as requirements development, 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. Work closely with pilot manufacturing line and operations group to develop a device build process.
  • Transducer subject matter expert:
    • Provide transducer and acoustic 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. Write product requirements and specifications to support feature. Plan, design, execute and report on system experiments as related to feature development and the product roadmap.
  • Test Methods:
    • Involved in writing test plans, procedures, and data analysis as it relates to technical requirements and specifications. Validation of the test tool or setup is usually required
Job related qualifications/skillsProfessional Experience
  • Required:
    • 10+ years' experience in design of piezoelectric or magneto strictive devices
    • 10+ years' experience within R&D product development
Knowledge, Skills, and Abilities
  • Required:
    • Knowledge of design for manufacturing, from feasibility through transfer to production
    • Familiarity with transducer characterization (impedance, acoustic tank, pulse-echo, force balance, transmitting voltage response)
    • Knowledge in Solidworks and Finite Element Analysis
  • Preferred:
    • Medical ultrasound transducers
    • Materials design and testing
    • Familiarity with acoustic standards (IEC , IEC , 21CFR1050.10, MIL-STD-1376)
Education
  • Required:
    • BS, Mechanical, Electrical, Biomedical Engineering or BS, Physics, Materials Science
  • Preferred:
    • MS, Mechanical, Electrical, Biomedical Engineering or MS, Physics, Materials Science

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR c) Research and Development

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