Senior Electrical Engineer, Combination Product Development

AbbVie•North Chicago, IL

3d•$96,500 - $183,500•Onsite

About The Position

We are seeking an experienced Sr. Electrical Engineer to support the development of innovative drug-device combination products within our Combination Product Development team in R&D. In this role, you will lead electrical system design efforts for clinical development of advanced drug delivery systems, including on-body injectors, subcutaneous ambulatory infusion pumps, and other electromechanical systems. This role will contribute to the development of new device and platform technologies, maintaining technical rigor and ensuring compliance with regulatory standards. This role will work closely with engineering colleagues in R&D and cross-functional colleagues in a global organization as well as maintaining strong working relationships with external development partners throughout the product development process.

Requirements

BS in Electrical Engineering or equivalent discipline, with typically 10+ years of relevant industry experience; MS in Electrical Engineering with typically 8+ years of relevant experience
Demonstrated experience in medical devices or combination product development
Demonstrated expertise in electrical system design for drug delivery systems
Advanced understanding of circuit design, PCB design, and embedded systems; experience having designed and developed electrical systems from concept through product launch is a plus
Proficiency with design tools, simulation software, and analytical modeling techniques
Solid knowledge of applicable global regulatory requirements and industry standards (e.g., 21 CFR 820.30, ISO 13485, MDR)
Understanding of modern, lean product development methodologies and stage/gate processes
Experience with design verification and validation protocols in regulated environments
Demonstrated ability to function as a technical leader, generating original technical ideas and development strategies
Possesses strong technical judgment and ability to work on problems of complex scope with competing factors
Excellent ability to work collaboratively with diverse groups within engineering and maintain strong working relationships with internal and external partners
Outstanding written and verbal communication skills with ability to clearly articulate technical challenges and solutions to stakeholders
Demonstrated project management capability and ability to balance multiple priorities
Proactive approach to identifying and resolving technical and project risks
Self-motivated with ability to operate independently

Nice To Haves

Prior experience with subcutaneous injection devices, electromechanical devices, or digital/connected health technologies is highly desirable

Responsibilities

Work closely with external development partners through design and development efforts associated with electronic components of drug delivery systems
Execute feasibility and initial development activities including needs definition, requirements, assessment of design fundamentals, and technology landscaping
Conduct system architecture evaluation, including assessment of system design, testing, and analysis of electrical components
Perform electronics design assessments including circuit design, PCB assessment, circuit analysis, evaluation of design margins, and testing requirements definition
Support system integration activities, reliability assessments, verification testing, and design validation to ensure products are technically robust and meet reliably goals
Provide engineering analysis and design history file documentation to support development activities, including Design Inputs, Design Outputs, Protocols, Task Analysis, and risk assessments
Support the lab and design verification teams with test plans, test setups, methods, investigations, and engineering confidence tests
Engage and collaborate with clinical, project development, regulatory, quality, and operations teams, as well as external engineering partners to ensure alignment throughout device development
Work across engineering disciplines (mechanical, software, systems engineering) to drive consensus and support execution on technical solutions
Partner with cross-functional stakeholders to ensure development deliverables and timelines meet regulatory standards and quality expectations
Establish and maintain working knowledge of technology trends and assess their relevance to combination product development
Partner with external vendors to understand and evaluate future technology roadmaps
Participate in and drive department continuous improvement initiatives focused on maximizing process efficiencies and enhanced collaboration
Use appropriate project management techniques and stage/gate processes to ensure successful completion of assigned projects