Sr Engineer Design Electrical

Medline Industries, LP•Northfield, IL

About The Position

The Senior Design Engineer researches, designs, develops, and supports complex medical devices with a focus on electrical and system design. This role provides technical leadership and subject matter expertise across the full product lifecycle, from concept through commercialization; leads electrical and system level design efforts; translates user needs into compliant design specifications; mentors junior engineers; collaborates cross functionally; and drives design excellence to support successful product launches and continuous improvement.

Requirements

Bachelor’s degree in Electrical Engineering, Electrical & Computer Engineering, Software Engineering, Biomedical Engineering, or a related engineering discipline
4+ years of experience in electrical and/or system level product design, preferably within a regulated industry.
Hands on experience with schematic capture, PCB design, and prototype bring up.
Advanced proficiency in Altium Design or equivalent E-CAD software.
Experience with prototype development, PCB manufacturing, design documentation, and design for manufacturability.
Experience working with embedded systems, including hardware software integration and system debugging.
Demonstrated experience working within a structured product development process, including exposure to design controls, risk management, and cross-functional collaboration.
Position requires travel up to 10% of the time for business purposes (domestic and international).
Strong understanding of electrical systems, embedded software interactions, and system engineering principles.
Ability to troubleshoot complex hardware software system issues.
Effective collaboration in multi disciplinary development teams.
Ability to manage technical risk and make sound engineering decisions in a regulated environment.
Familiarity with regulatory standards including IEC 60601 Series, FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
Effective communication and collaboration skills, with experience working in cross-functional teams.

Nice To Haves

Experience in product design within the medical device industry, including development and launch of Class II devices.
Strong understanding of design controls, risk management (e.g., FMEA), and regulatory documentation (e.g., DHF, DMR, traceability matrices).
Familiarity with medical electrical safety, EMC, and compliance testing (IEC 60601, IEC 62304, ISO 14971).
Experience with embedded firmware/software development or architecture, including requirements definition and verification.
Experience leading or significantly contributing to cross disciplinary system architectures.
Experience supporting products through manufacturing scale up and sustaining engineering.
Strong technical documentation, communication, and project coordination skills.

Responsibilities

Lead the electrical and system level design of medical devices, including architecture definition, requirements decomposition, and interface control across hardware, firmware, and software domains.
Design and develop electrical schematics, PCB layouts, and supporting documentation using ECAD tools.
Contribute to and review software and firmware architectures, ensuring robust integration with electrical hardware and system requirements.
Drive design transfer activities, ensuring smooth transition from R&D to manufacturing through validation builds, process development, and troubleshooting.
Support intellectual property strategy by identifying novel design concepts and partnering with legal to secure patents.
Define and manage system requirements, perform feasibility studies, and ensure traceability through design inputs, outputs, verification, and validation activities.
Integrate human factors and user centered design philosophies into product development to enhance safety, effectiveness, and user satisfaction.
Lead multi-disciplinary product development teams to research, design, and develop better products and technologies.
Ensure product designs meet all design specifications.
Manage multiple projects by coordinating resources, and priorities to meet development milestones and business objectives.
Evaluate and improve existing products through root cause analysis, risk assessments, and feedback from users, manufacturers, and post-market surveillance.
Contribute to innovation pipelines by collaborating with product divisions to identify new product opportunities, and align product design efforts with long-term strategic goals.