Principal Electrical Device Design Engineer - Indianola, PA

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.

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.

• 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, 21
  
  CFR
  820, ISO 14971, 21
  
  CFR
  820.30, 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.

• Bachelor's degree in Electrical Engineering, Biomedical…