
Senior Electrical Engineer, Combination Product Development
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.
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
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
Prior experience with subcutaneous injection devices, electromechanical devices, or digital/connected health technologies is highly desirable
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
R&D team members (mechanical engineering, software engineering, systems engineering)
Regulatory and Quality Assurance functions
Operations and Supply Chain teams
Clinical and Commercial teams
External development partners
Project management and cross-functional leadership
Travel (domestic and/or international) may be required depending on project assignments (estimated 5%-10%)
This role requires strong attention to detail and commitment to quality and regulatory compliance
The successful candidate will demonstrate a passion for advancing innovative drug delivery technologies
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
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https://www.abbvie.com/join-us/reasonable-accommodations.html
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