Senior Systems Engineer - Medical Devices (Electromechanical)
Overview
Systems Ally seeks Senior Systems Engineer to lead design and development of complex medical devices. This hands-on role supports products from concept through launch. Ideal candidate translates user needs into system design while ensuring safety reliability usability and regulatory compliance.
What You'll Do30
- 1Lead and execute Systems Engineering activities throughout the medical device product development lifecycle
- 2Translate User Needs into system requirements and measurable design inputs
- 3Develop and maintain system-level and subsystem requirements including functional performance safety reliability interface and environmental criteria
- 4Create and maintain requirements traceability from User Needs through system requirements design outputs verification validation and risk controls
- 5Develop system architecture functional decomposition system interfaces and allocate requirements to mechanical electrical software firmware controls and other subsystems
- 6Work closely with Mechanical Electrical Software/Firmware Quality Regulatory Manufacturing and Clinical teams
- 7Lead or support Systems Engineering deliverables for new product development enhancements and design changes
- 8Develop and review System Verification and Validation strategies plans protocols test methods and reports
- 9Support design verification testing including requirements-based verification and evaluation of system-level performance
- 10Support design validation evaluating complete device against User Needs and Intended Use
- 11Perform Systems Hazard Analysis Fault Tree Analysis Failure Modes and Effects Analysis and other risk analyses
- 12Identify safety hazards hazardous situations foreseeable misuse system failure modes and risk controls
- 13Ensure risk controls are appropriately translated into system and subsystem requirements and verified through the design process
- 14Support development and maintenance of Design History File and other design control documentation
- 15Participate in technical design reviews requirements reviews architecture reviews risk reviews and design verification/validation reviews
- 16Analyze system-level problems and lead cross-functional root-cause investigations and corrective actions
- 17Evaluate system performance interfaces failure modes interactions between hardware software mechanical components sensors actuators motors controllers and users
- 18Support design transfer manufacturing readiness production issues and post-launch product improvements
- 19Identify opportunities to improve Systems Engineering processes tools templates requirements management traceability and risk management
- 20Apply FDA medical device design controls and Quality Management System Regulation 21 CFR Part 820 throughout product development
- 21Work within ISO 13485 quality management and medical device design and development processes
- 22Apply ISO 14971 medical device risk management principles to system design and development
- 23Apply IEC 60601 requirements for applicable electrical medical equipment and systems
- 24Apply IEC 62304 principles and requirements when medical device software or embedded software is part of the system
- 25Apply IEC 62366-1 usability engineering principles when applicable to the device and user interface
- 26Support regulatory and quality requirements applicable to the product's intended markets including FDA and international medical device requirements
- 27Understand system-level safety performance alarm human factors fluid delivery dosing occlusion power sensor actuator and software-related risks associated with infusion pumps and drug delivery products
- 28Experience with FDA Infusion Pumps Total Product Life Cycle guidance is highly desirable
- 29Experience with automated medication/drug dispensing or pharmacy automation systems is highly desirable
- 30Familiarity with ISO 14971 complex devices involving software mechanical components batteries and fluid delivery systems is essential
Requirements22
- 1Bachelor's degree in Systems Engineering Biomedical Engineering Electrical Engineering Mechanical Engineering Computer Engineering Computer Science or related discipline
- 25+ years of Systems Engineering experience in the medical device industry preferably in new product development or R&D
- 3Strong hands-on experience with medical device design and development
- 4Strong understanding of Systems Engineering processes requirements engineering system architecture risk management verification validation and traceability
- 5Experience developing and managing system requirements and requirements traceability matrices
- 6Experience with medical device design controls and Design History File documentation
- 7Experience performing or supporting Hazard Analysis FMEA risk analysis and risk control activities in accordance with ISO 14971
- 8Experience developing or supporting system-level verification and validation
- 9Working knowledge of FDA medical device requirements QMSR 21 CFR Part 820 ISO 13485 and ISO 14971
- 10Experience with a requirements management ALM PLM or traceability tool
- 11Strong technical writing problem-solving communication and cross-functional collaboration skills
- 12Experience with infusion pumps smart pumps syringe pumps drug delivery systems dialysis machines robotic surgery devices automated drug dispensing systems medication dispensing equipment pharmacy automation or other medication-management devices
- 13Experience with complex electromechanical medical devices
- 14Experience with robotics automation motion control sensors actuators motors pumps valves controllers or embedded systems
- 15Experience with MBSE and tools such as Cameo MagicDraw Enterprise Architect or similar platforms
- 16Experience with DOORS Jama Polarion Siemens Teamcenter Windchill or other requirements/ALM/PLM platforms
- 17Experience with IEC 60601-1 IEC 60601-1-2 IEC 62304 IEC 62366-1 or other applicable medical device standards
- 18Experience with Fault Tree Analysis FMEA Fault Analysis Reliability Engineering or Safety Engineering
- 19Experience supporting FDA submissions design reviews design transfer or regulatory inspections/audits
- 20Experience working on products containing embedded software firmware electrical systems sensors motors actuators pumps valves fluidics automated mechanisms and controls
- 21User interfaces and alarms safety and risk controls clinical workflows and human factors system-level verification and validation
- 22Medical Device Systems Engineer Senior Systems Engineer Systems Engineering Medical Devices Electromechanical Systems Medical Device R&D Requirements Engineering Systems Requirements System Architecture System Design Design Controls Design Verification Design Validation V&V Risk Management ISO 14971 ISO 13485 FDA QMSR 21 CFR Part 820 IEC 60601 IEC 62304 IEC 62366-1 FMEA dFMEA Hazard Analysis Fault Tree Analysis FTA Requirements Traceability Traceability Matrix ALM MBSE Medical Device Development Infusion Pumps Smart Pumps Drug Delivery Automated Drug Dispensing Medication Dispensing Pharmacy Automation Robotics Sensors Actuators Motors Pumps Valves Embedded Systems Firmware Controls Electrical Engineering Mechanical Engineering
Salary Insight
$87 - $158k per year
Location
Required Skills
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