Systems Ally · 2 days ago
Senior Combination Electromechanical Engineer
North Chicago, IL
Contract
Onsite
Senior Level
5+ years expSystems Ally is seeking a Senior Combination Electromechanical Engineer with deep technical expertise in infusion systems and electromechanical medical devices. This highly technical and hands-on role focuses on the development, commercialization, and lifecycle management of drug-device combination products, requiring strong cross-functional collaboration across various teams.
ConsultingLife ScienceMedical
No H1B
Hiring Manager
Vishal Meena
Responsibilities
Serve as a core technical contributor for drug–device combination products, with emphasis on infusion and delivery systems
Support design, development, verification, validation, and lifecycle management of electromechanical infusion devices
Provide engineering leadership on device architecture, system integration, and drug–device interfaces
Evaluate device performance, reliability, usability, and safety to meet clinical, regulatory, and patient needs
Apply deep knowledge of electromechanical systems, including: Motors, sensors, actuators; Batteries, power management, and electronics; Firmware interfaces and mechanical assemblies
Support infusion-specific requirements such as: Flow rate accuracy and dose delivery; Occlusion detection and alarm systems; Reliability, robustness, and power efficiency
Partner with software, electrical, and mechanical teams to resolve system-level technical challenges
Lead or support failure analysis, root cause investigations, and corrective actions related to device performance
Ensure compliance with FDA Design Controls, ISO standards, and internal quality systems
Author, review, and maintain critical technical documentation, including: Design inputs and outputs; Risk Management Files (ISO 14971); Verification & Validation (V&V) protocols and reports; DHF, DMR, and technical assessments
Support regulatory submissions and responses related to combination products, including components of NDA, BLA, 510(k), or PMA filings
Work closely with Quality, Regulatory Affairs, Clinical, Manufacturing, Supply Chain, and Project Management teams
Act as a technical liaison with external device suppliers, CMOs, and development partners
Support technology transfer, manufacturing readiness, and scale-up activities
Participate in design reviews, hazard analyses, and usability evaluations
Support post-market surveillance, complaint investigations, CAPAs, and change management
Drive continuous improvement initiatives to enhance device performance, reliability, and patient experience
Stay current with evolving combination product regulations, infusion technologies, and industry standards
Qualification
Required
Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related field
5–10+ years of experience in medical device or combination product development
Demonstrated, hands-on experience with infusion devices or drug delivery systems
Strong background in electromechanical systems and system-level integration
Experience working in a highly regulated environment (FDA, ISO 13485, IEC 60601, etc.)
Solid understanding of design controls, risk management, and V&V
Strong technical writing skills with experience authoring regulated documentation
Proven ability to collaborate across functions and with external partners
Preferred
Experience supporting drug–device combination products within a pharmaceutical organization
Familiarity with on-body, wearable, or ambulatory infusion systems
Experience with Human Factors / Usability Engineering (IEC 62366)
Exposure to post-market support, complaint handling, and CAPA investigations
Advanced degree (MS or PhD) in Engineering or related discipline
Company
Systems Ally
Systems Ally offers consulting services for life sciences and technology, focusing on medical devices, pharmaceuticals, and healthcare.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase