Electrical Development Engineer Principal I

Biomet Microfixation, LLC•Minneapolis, MN

13d

About The Position

The Electrical Development Engineer Principal I serves as a design owner and/or key project contributor responsible for the design, development, and commercialization of new products’ electrical elements, and/or for maintaining innovative medical device products on the market. The role identifies and applies new technologies to support these goals and mentors less senior Development staff. The position translates user needs into design requirements and creates product designs, hardware specifications, and design rationale. It coordinates prototype production and inspection, design verification and validation, process validation, and supports design transfer to production. The engineer also evaluates designs for compliance with internal procedures and global regulatory requirements, reduces user risk, and helps ensure suitable quality-control inspection plans.

Requirements

Minimum B.S. degree from an ABET-accredited school or global equivalent in Electrical Engineering or Electrical Engineering Technology.
At least 7 years of full-time engineering experience, including relevant Zimmer Biomet co-op or internship experience.
Demonstrated written and verbal communication skills and ability to deliver professional communications to a global audience.
Proficiency with Microsoft Office Suite.
Knowledge of FDA QSR and EU MDR medical-device regulatory requirements and recognized industry or regulatory-body technical product standards.
Experience with design and testing of printed circuit board assemblies for embedded and electrical systems using an enterprise-level EDA package such as Mentor Graphics or Altium.
Experience with embedded microprocessor design, schematic capture, printed circuit board layout, and simulation tools.
Strong understanding of hardware interfaces and I/O, including SPI, UART, A/D, D/A, I2C, CAN, LVDS, and MIPI.
Ability to perform board bring-ups using advanced debugging and troubleshooting techniques.
Board-level EMC design experience and experience supporting product-level EMC testing and EMC issue resolution.

Nice To Haves

Product design and development experience with a multidisciplinary project team from user-need identification and concept ideation through commercialization; medical-device experience, particularly orthopedic implant and instrument product design, is desired.
Understanding of electrical/electronic manufacturing processes, including printed circuit board assembly manufacturing, and material science as applied to new product development.
Knowledge of global medical-device regulatory requirements.
Working knowledge of statistics applied to sample-size determination, design of experiments, and null-hypothesis testing.
FPGA/CPLD design proficiency using VHDL or Verilog.
Bluetooth and wireless design experience.
Motor-control experience, especially with BLDC motors.
Li-ion battery-pack management experience.
Minitab experience.

Responsibilities

Stay current with relevant medical electrical standards and regulations.
Help identify user needs through engagement with internal teams and observation of similar device usage.
Translate targeted user needs into design requirements and inputs that address unmet market needs, business goals, global regulatory requirements, and recognized external industry standards.
Create product designs that address targeted user needs and requirements, and author design rationale documenting the basis for design features.
Prepare and review information for invention disclosures and patents.
Initiate, instruct, and coordinate with cross-functional team members on prototype production and inspection for preliminary evaluation, final design verification and validation, and process validation.
Create hardware requirements specifications and hardware design details, including design elements that account for manufacturability, process capability, in-circuit testability, and inspection needs.
Identify and document critical-to-quality product features based on intended use, design requirements, user risks, and the design, to support appropriate quality-control inspection plans.
Evaluate, verify, and validate product designs against design requirements and to reduce user risk, in compliance with Zimmer Biomet procedures and global regulatory requirements; activities include tolerance stack-ups, benchtop testing, and simulated operating-room cadaveric product evaluations.
Support Quality, Sourcing, and Manufacturing teams with new-product design-transfer tasks for production of market-release quantities.
Mentor less senior Development staff within the department.