Principal Electrical Device Design Engineer - Indianola, PA

Bayer (Schweiz) AG; Pennsylvania; On-site; USD 118,000 - 177,000; Full time

Benefits offered by this job

Health care

Vision

Dental

Retirement plan

PTO

Sick leave

Job summary

Bayer AG in Indianola, PA is seeking a Principal Electrical Device Design Engineer to lead design development and life cycle activities for medical device and drug-device products. You will evaluate technologies, design PCB/subsystems, and author critical design and DHF documentation while ensuring MDR/IEC 60601 compliance.

The role requires extensive experience in electrical hardware design for medical devices, strong cross-functional collaboration, and expertise with ECAD tools.

Qualifications

• Bachelor's degree in Electrical or Biomedical Engineering.
• Several years in the Medical Device & Drug-Device industry focusing on electrical hardware design.
• Experience leading electrical product development activities.
• Knowledge of standards (21CFR820, ISO 13485, IEC 60601, IEC 62304, ISO 14971).
• Proficiency with ECAD tools and firmware integration.

Responsibilities

• Plan and execute electrical design development and life cycle activities.
• Evaluate new electrical technologies to establish robust requirements.
• Design, develop, and validate PCB, power, embedded systems, sensors.
• Create design documentation and DHF maintenance.
• Coordinate with global project teams and external partners.
• Ensure regulatory compliance (MDR, ISO 13485, IEC 60601).
• Lead EMC and electrical safety testing planning.

Skills

Electrical design

Embedded systems

Regulatory knowledge

Cross-functional teamwork

Analytical skills

Education

Bachelor’s in Electrical/Biomedical Engineering

Master’s degree preferred

Tools

Altium Designer

OrCAD Cadence

Mentor Xpedition

ECAD tools

Job description

- Relevant skills and experience will be listed so you know why those jobs are a match## Job Description**At Bayer, we believe work should matter. Every day, our teams push toward a future where \"Health for all, Hunger for none\" is within reach, and every role, from the lab to the field to the boardroom, helps us get there. We give people the ownership to shape outcomes, the support to grow through new skills and experiences, and a global community where different perspectives are valued. If you want your work to count and the room to become your best, you'll find it here.****Principal Electrical Device Design Engineer - Indianola, PA****Principal Electrical Device Design Engineer - Indianola, PA****PURPOSE**Responsible for the design, planning, execution, documentation, commissioning, and handover of specific technical work packages, ensuring they are completed on time and within budget. This role involves detailed engineering for a specific discipline, including the design, calculation, and specification of related engineering documents, as well as field engineering. The Project Engineer stays current with best practices and relevant internal and external regulations, implementing these standards throughout the project lifecycle.**YOUR TASKS AND RESPONSIBILITIES*** Plan, coordinate, and execute Electrical Design Development and Life Cycle Engineering activities to successfully bring new Medical Device & Drug-Device Combination Products to the market and continuously improve the marketed Bayer Product Supply Product Portfolio;* Evaluation of new and breakthrough electrical/electronic technologies by applying theoretical and practical engineering knowledge, to establish robust technical product requirements, and develop electrical engineering design solutions to assure products maintain the required level of performance throughout the life of the product;* Design, develop, and validate electrical and electronic subsystems including printed circuit board (PCB) design, power management, embedded systems, sensor integration, motor/actuator drive circuits, and signal conditioning;* Author technical documentation (e.g., Design Development Plans, User Requirements Specifications, Electrical Design Inputs, Electrical Design Outputs, schematic capture, circuit analysis reports, and DHF creation/maintenance of DHF documentation), conformity assessments and risk management documentation;* Represent the electrical design engineering team within global project teams and execute projects independently within the agreed time, quality, and cost constraints, resulting in state-of-the-art drug delivery and diagnostic systems;* Provide technical consulting and support the management of technical interfaces towards our internal and external development partners, including contract electronics manufacturers and PCBA suppliers;* Apply knowledge of the drug and medical devices regulatory landscape to ensure standard-compliant electrical designs according to MDR, ISO 13485, 21CFR820, ISO 14971, 21CFR820.30, IEC 60601 (including sub-standards for EMC, safety, and essential performance), IEC 62304, ISO 11608, ISO 11040, and applicable EMC/EMI directives;* Perform and support electromagnetic compatibility (EMC) testing, electrical safety testing, and ensure designs meet applicable immunity and emissions requirements per IEC 60601-1-2;* Continuous improvement of our electrical development and life cycle engineering processes, including design for manufacturability (DFM), design for testability (DFT), and design for reliability;* Serve as a Subject Matter Expert to support multiple technical activities like electrical design transfers, root cause analysis of electrical/electronic failures, and technical registration documents;* Support less experienced electrical design team members in complex projects and general skill development.**WHO YOU ARE**Bayer seeks an incumbent who possesses the following:**REQUIRED QUALIFICATIONS*** Bachelor's degree in Electrical Engineering, Biomedical Engineering, or a closely related engineering discipline;* Multiple years of work experience in the Medical Device & Drug-Device Combination Product industry with a focus on electrical/electronic hardware design and sustenance;* Minimum 3 years of experience contributing to the leadership of electrical product development activities and projects* Broad understanding of a variety of applicable standards and regulations (e.g., 21CFR820, ISO 13485, IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971, IEC 61010, UL/CSA standards, EU MDR, and applicable EMC directives) is required;* Demonstrated experience at utilizing Design Control processes to develop, launch, and sustain medical devices and combination products with electrical/electronic subsystems;* Proficiency in electrical CAD tools for schematic capture and PCB layout (e.g., Altium Designer, Cadence OrCAD, Mentor Graphics/Siemens Xpedition, or equivalent);* Experience with coordinating the work of other internal and external electrical design team members;* Knowledge of multiple electrical/electronic technologies, such as analog and digital circuit design, power supply design (AC/DC, DC/DC), embedded microcontroller/microprocessor systems, wireless communication protocols (Bluetooth, Wi-Fi, NFC), sensor interfaces, and motor control;* Familiarity with firmware/software integration and working knowledge of embedded software development practices (IEC 62304) to effectively collaborate with firmware engineering teams;* Familiarity with equipment, test methods, and best practices applicable to the verification and validation of electrical product designs, including oscilloscopes, spectrum analyzers, logic analyzers, and environmental test chambers;* Strong quantitative and qualitative analytical background and skills to understand and interpret analytical and test results (e.g., signal integrity analysis, thermal analysis, power consumption characterization, EMC pre-compliance testing);* Good statistical background and very good IT skills (e.g., Excel, Minitab, MATLAB, SPICE simulation tools);* Ability to contribute to and support project execution by leveraging cross-functional relationships;* Proficient in the English language, both written and verbal.**PREFERRED QUALIFICATIONS*** Master's degree in Electrical Engineering or a related scientific discipline;* 10 years of work experience in the Medical Device & Drug-Device Combination Product industry with a focus on electrical/electronic hardware design and sustenance.Employees can expect to be paid a salary between $117,760.00 to $176,640.00. Additional compensation may include a bonus or incentive compensation (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc...This salary range is merely an estimate and may vary based on an applicant's location, market data/ranges, an applicant's skills and prior relevant experience, certain degrees and certifications, and other relevant factors.This posting will be available for application until at least 11-16-26.| | || - | - | - | - | - || | | | | || **YOUR APPLICATION** | | | | || | | | | || | || - | - | - | - | - || Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Health for all, Hunger for none, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer. To all recruitment agencies: Bayer does not accept unsolicited third party resumes. Bayer is an Equal Opportunity Employer/Disabled/Veterans Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. | | | | || Equal Opportunity Employer Statement: Notice for U.S. Visitors: