Principal Electrical Device Design Engineer - Indianola, PA

Bayer•Indianola, PA

3d•$117,760 - $176,640

About The Position

The Principal Electrical Device Design Engineer is responsible for planning, executing, documenting, commissioning, and handing over technical work packages on time and within budget. The role provides detailed electrical engineering, including design, calculations, specifications, and field engineering, while applying relevant best practices and internal and external regulations throughout the project lifecycle. The engineer leads electrical design development and lifecycle engineering for medical devices and drug-device combination products, supporting new product launches and continuous improvement of Bayer’s marketed product portfolio. This includes evaluating technologies, establishing product requirements, and designing and validating electrical and electronic subsystems such as PCBs, power management, embedded systems, sensor integration, motor and actuator drive circuits, and signal conditioning. The position authors design-control, technical, conformity-assessment, and risk-management documentation; represents electrical design engineering on global project teams; and coordinates technical interfaces with internal and external development partners, including contract electronics manufacturers and PCBA suppliers. It applies medical-device regulatory and standards knowledge, supports EMC and electrical-safety testing, improves development and lifecycle engineering processes, serves as a subject matter expert, and supports less experienced team members.

Requirements

Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or a closely related engineering discipline.
Multiple years of work experience in the medical device and drug-device combination product industry focused on electrical/electronic hardware design and sustenance.
At least 3 years of experience contributing to the leadership of electrical product development activities and projects.
Broad understanding of applicable standards and regulations, including 21 CFR 820, ISO 13485, IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971, IEC 61010, UL/CSA standards, EU MDR, and applicable EMC directives.
Demonstrated experience using design control processes to develop, launch, and sustain medical devices and combination products with electrical/electronic subsystems.
Proficiency with electrical CAD tools for schematic capture and PCB layout, such as Altium Designer, Cadence OrCAD, Mentor Graphics/Siemens Xpedition, or equivalent.
Experience coordinating the work of internal and external electrical design team members.
Knowledge of electrical/electronic technologies such as analog and digital circuit design, AC/DC and DC/DC power supplies, embedded microcontroller/microprocessor systems, Bluetooth, Wi-Fi and NFC, sensor interfaces, and motor control.
Familiarity with firmware/software integration and working knowledge of embedded software development practices, including IEC 62304.
Familiarity with equipment, test methods, and best practices for electrical product design verification and validation, including oscilloscopes, spectrum analyzers, logic analyzers, and environmental test chambers.
Strong quantitative and qualitative analytical skills for interpreting analytical and test results, including signal integrity, thermal, power consumption, and EMC pre-compliance results.
Good statistical background and very good IT skills, including Excel, Minitab, MATLAB, and SPICE simulation tools.
Ability to contribute to project execution by leveraging cross-functional relationships.
Proficiency in written and verbal English.

Nice To Haves

Master’s degree in Electrical Engineering or a related scientific discipline.
10 years of work experience in the medical device and drug-device combination product industry focused on electrical/electronic hardware design and sustenance.

Responsibilities

Plan, coordinate, and execute electrical design development and lifecycle engineering activities for medical devices and drug-device combination products.
Evaluate new and emerging electrical and electronic technologies, establish technical product requirements, and develop robust electrical design solutions.
Design, develop, and validate electrical and electronic subsystems, including PCB designs, power management, embedded systems, sensor integration, motor and actuator drive circuits, and signal conditioning.
Author technical documentation, including design development plans, user requirements specifications, electrical design inputs and outputs, schematics, circuit analysis reports, and design history file documentation.
Prepare conformity assessments and risk-management documentation.
Represent the electrical design engineering team on global project teams and execute projects within agreed time, quality, and cost constraints.
Provide technical consulting and manage technical interfaces with internal and external development partners, contract electronics manufacturers, and PCBA suppliers.
Apply applicable medical-device and drug-device regulations and standards to electrical designs.
Perform and support EMC and electrical-safety testing, ensuring applicable immunity and emissions requirements are met.
Continuously improve electrical development and lifecycle engineering processes, including design for manufacturability, testability, and reliability.
Serve as a subject matter expert for electrical design transfers, root-cause analysis of electrical and electronic failures, and technical registration documents.
Support less experienced electrical design team members on complex projects and in general skill development.