Electrical Development Engineer Principal I

You have a design owner and/or key project role with responsibility for new product design, development, and commercialization relative to all electrical elements; and/or to maintain in the market innovative medical device products in order to further Zimmer Biomet’s mission and grow Zimmer Biomet’s market leadership position.

Additionally, you will identify and put into application new technologies to serve the above goals. You will mentor less senior Development staff within the department.

Stays current with and understands relevant medical electrical standards and regulations.

Helps in identifying user needs through engagement with internal teams and observation of similar device usage.

Translates targeted user needs into design requirements/inputs which satisfy unmet market needs to achieve business goals while also complying with global regulatory requirements and recognized external industry standards

Creates product designs which fully address targeted user needs/requirements, and authors design rationale to document basis of all design features

Prepares and reviews information for invention disclosures and patents

Initiates, provides instruction for and coordinates with support from Zimmer Biomet cross-functional team members in the production and inspection of product prototypes for preliminary evaluation; and final design verification, design validation and process validation

Creates hardware requirements specifications which defines what the design is intended to do as well as hardware design details which defines how the design is intended to meet specifications. Also provides design elements that appropriately account for design, design for manufacturability (process capability). in-circuit testability and other inspection groundwork.

Identifies and documents critical to quality product features based on product intended use, design requirements, associated user risks and the design itself to ensure appropriate quality control inspection plans are generated

Evaluates, verifies and validates product designs relative to design requirements and to reduce user risk in compliance with Zimmer Biomet procedures and global regulatory requirements (includes completing tolerance stack-ups, benchtop testing and executing simulated operating room cadaveric product evaluations)

Supports Zimmer Biomet Quality, Sourcing and Manufacturing teams with new product design transfer tasks for production of market release quantities

Demonstrated good written and verbal communication skills, able to deliver professional communications to a global audience base

Microsoft Office Suite software proficiency required

Demonstrated product design and development execution with a multi-disciplinary project team from user need identification/concept ideation through commercialization desired; medical device particularly orthopedic implant and instrument product design desired

Demonstrated a general understanding of various electrical/electronic manufacturing processes (including PCB printed circuit board assembly manufacturing,) and material science for application in new product development

FDA QSR and EU MDR medical device regulatory requirements, and industry/regulatory body recognized technical product standards knowledge required; global medical device regulatory requirements knowledge preferred

Demonstrated working knowledge of statistics with application to sample size determination, design of experiments and null hypothesis testing preferred.

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 (SPI, UART, A/D, D/A. I2C, CAN. LVDS, MIPI, ect)

Ability to execute board bring-ups by using advanced debugging and troubleshooting techniques.

Board level EMC design experience, supporting product level EMC test and EMC issue reolution.

FPGA/CPLD design proficiency with VHDL (or Verilog) language preferred.

Bluetooth and wireless design experience desired.

Motor control experience especially with BLDC desired.

Li-ion battery pack management desired.

Minitab experience preferred.

Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Electrical Engineering or Electrical Engineering Technology.

7+ years of full-time (including relevant ZB Coop/Intern) engineering experience.

EOE/M/F/Vet/Disability