This listing doesn't post a salary. Most similar roles pay
$135,000–$204,262.
Based on 240 similar postings.
Employer
About AbbVie
AbbVie is a global biopharmaceutical company focused on discovering and delivering innovative medicines and solutions in immunology, oncology, neuroscience, and eye care. Its products include Humira, Skyrizi, and Rinvoq.
AbbVie currently has
297 open roles
on FindRole.
Listed pay typically runs
$109,500–$208,500
across 271 roles with salary data.
As a Senior Systems Engineer within the Device and Combination Product Development team in R&D, you will drive the implementation of holistic Systems Engineering principles throughout the Design Controls process. You will manage system architecture, integration, traceability, risk management, and DHF architecture while defining user needs and product requirements for aesthetic devices and therapeutic combination products. Your daily work involves overseeing third-party development activities, coordinating testing plans with cross-functional teams, and ensuring compliance with safety and regulatory standards like FDA 21 CFR Part 820.30 and ISO 14971. You will manage complex drug delivery systems, including syringes, autoinjectors, and electromechanical pumps. The role requires expertise in configuration management, change management, and scientific writing to ensure robust, patient-centric designs for clinical and commercial development programs within the aesthetic filler product space.
What does a Systems Engineer earn?
Median $158250 from 186 postings across 30 companies.
Implement Systems Engineering principles including architecture, traceability, and risk management within the Design Controls process.
Define and manage user needs, stakeholder requirements, and applicable standards throughout the product development lifecycle.
Lead system-related risk management activities, including risk planning, reporting, and design/process FMEAs.
Oversee third-party development activities to ensure alignment with Design Control and Quality by Design standards.
Coordinate testing activities and manage sample and laboratory resource planning across cross-functional teams.
Own key project deliverables as the dedicated systems engineer for various medical device and combination product programs.
Ensure all system designs and documentation comply with safety, regulatory requirements, and DHF management standards.
What we're looking for
Bachelor’s degree in Engineering or Science with 7+ years of experience, or a Master’s degree with 5+ years of experience.
Proven ability to provide technical leadership ensuring system design and documentation comply with safety and regulatory requirements.
Expertise in Systems Engineering principles including risk management, product architecture, configuration management, traceability, and change management.
Expertise in DHF management and creating Design Control documents in compliance with regulations.
Experience working with third-party vendors and intercultural competence in a global environment.
Proficiency in English and German is required.
Experience in combination product or medical device development with familiarity with FDA 21 CFR, ISO 14971, ISO 13485, and EU MDR (preferred).
Experience with Aesthetic Filler products (preferred).
Electrical System Design
Circuit Design
PCB Design
Embedded Systems
Drug Delivery Systems
Electromechanical Systems
Design Verification
Design Validation
Risk Assessment
21 CFR 820.30
ISO 13485
MDR
Simulation Software
Analytical Modeling
Stage/Gate Process
Lean Product Development
Systems Engineering
Integration & Test
Configuration Management
Rust
Python
C
MATLAB
R
SQL
Linux
Command Line Interface
JAMA
Design-Build-Test (DBT)
Requirements Management
Robotics
Autonomous Systems