Principal Electrical Device Design Engineer - Indianola, PA

Bayer•Indiana Township, PA

4d•$117,760 - $176,640

About The Position

The Principal Electrical Device Design Engineer is responsible for the design, planning, execution, documentation, commissioning, and handover of technical work packages, ensuring completion on time and within budget. The role performs discipline-specific detailed engineering, including design, calculations, specifications, and field engineering, while applying relevant best practices and regulations throughout the project lifecycle. The engineer plans and carries out electrical design development and lifecycle engineering for new medical devices and drug-device combination products, as well as continuous improvement of Bayer’s marketed product-supply portfolio. The role evaluates electrical and electronic technologies; develops and validates electrical subsystems; authors technical, conformity, and risk-management documentation; and represents electrical engineering within global project teams. It also provides technical support to internal and external development partners, ensures regulatory and standards compliance, supports EMC and electrical-safety testing, improves 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 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 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 multiple electrical/electronic technologies, including analog and digital circuit design, AC/DC and DC/DC power supplies, embedded microcontroller or microprocessor systems, wireless protocols, 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 verification and validation, including oscilloscopes, spectrum analyzers, logic analyzers, and environmental test chambers.
Strong quantitative and qualitative analytical skills, including the ability to interpret signal-integrity, thermal, power-consumption, and EMC pre-compliance results.
Good statistical background and very good IT skills, such as Excel, Minitab, MATLAB, and SPICE simulation tools.
Ability to support project execution by leveraging cross-functional relationships.
Proficiency in written and spoken English.

Nice To Haves

Master’s degree in Electrical Engineering or a related scientific discipline.
10 years of 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 new medical devices and drug-device combination products and the ongoing improvement of marketed products.
Evaluate new electrical and electronic technologies and develop robust technical requirements and electrical design solutions.
Design, develop, and validate electrical and electronic subsystems, including PCB design, 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 in global project teams and independently execute projects within agreed time, quality, and cost constraints.
Provide technical consulting and manage technical interfaces with internal and external development partners, including contract electronics manufacturers and PCBA suppliers.
Apply medical-device regulatory and standards knowledge to ensure compliant electrical designs.
Perform and support electromagnetic compatibility and electrical-safety testing, and ensure designs meet applicable immunity and emissions requirements.
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 developing their skills.