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 principal engineer will be responsible for transducer design efforts in house as well as managing external design partners. Responsible for providing cross functional technical expertise when collaborating with project management, operations, regulatory, and clinical groups.

Responsibilities 

• Designs, builds, and tests ultrasound transducers per 21CFR820 using a design for manufacturing approach. Design scope includes electro-mechanical devices involving motion, ultrasound imaging and energy based therapy delivery.
• Scope of work includes simulations, fabrication, testing as well as requirements development, test plans/protocols and their execution design verification testing and document preparation clinical trials and 510K submissions.
• Design proof of concept transducers to prove feasibility for design requirements and manufacturability. 
• 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.
• Provide transducer and acoustic technical expertise for ultrasound beamforming and piezo-electric material composition, design, and impedance matching.
• Strong ultrasound simulation methods which may include transducer design, beam propagation, beam steering and focusing, absorption in complex media, and bio-heat modeling
• Ensure compliance to the requirements of ISO 13485 standards, FDA regulations and Good Manufacturing Processes regarding design and development of new product designs and product upgrades.
• Substantiate product design by developing test plans, performing design analysis, making design adjustments, running performance calculations, and maintaining quality standards.
• Write request for proposals for design partners; revise the statement of work; manage deliverables.

Education

• BS, Mechanical, Electrical, Biomedical Engineering or BS, Physics, Materials Science required
• MS, Mechanical, Electrical, Biomedical Engineering or MS, Physics, Materials Science preferred

Professional experience

• 12 years total industry experience
• 3 years’ experience in design of piezoelectric or magnetostrictive devices
• 5 years’ experience in design of ultrasound transducers
• 7 years’ experience within R&D product development

Knowledge, skills, and abilities

• Knowledge of design for manufacturing, from feasibility through transfer to production
• Experience with transducer characterization (impedance, acoustic tank, pulse-echo, force balance, transmitting voltage response)
• Experience designing medical ultrasound transducers
• Experience with ultrasound material composition.
• Knowledge of acoustic standards (IEC 60601-2-62, IEC 60601-2-37, 21CFR1050.10, MIL-STD-1376)
• SolidWorks
• Finite Element Analysis (FEA)
• FDA Design Controls for medical devices
• EU Medical Device Directive (CE Marking requirements)
• Understanding and experience in product design and development including the use of tools such as FEA, Risk Analysis, DFMA, GD&T, and DFMEA
• Ability to collaborate, communicate and coordinate cross-functionally.