System Engineer providing technical leadership for new product release and sustaining activity. Collaborating with a team to develop high-quality engineering solutions for medical devices.
Responsibilities
Overall technical leadership and responsibility for realization of a new product release and sustaining activity.
Translation of user requirements, requirements management, top-level design, feasibility of potential solutions, decomposition of derived requirements
Systems design/architecture and Integration oversight.
Support for NPI efforts that create value for Clinical Applications and Devices Organization through innovation and design, while delivering high quality engineering solutions.
Technical liaison to the program
Defect/Risk management and Design Reviews
Requirements
BS degree in engineering
Experience leading medical, or other regulated industry, product development
Experience in leading groups to solutions for complex problems
Experience with deriving and simulating human interactions with devices and device use conditions
Experience with electronic requirement data management SW – preferably DOORS
Minimum five years engineering / R&D experience in a rigorous quality-focused environment
Minimum three years’ experience in a Systems Engineering role, or a role having overall systems responsibility involving electrical (analog and digital), mechanical, firmware and software development disciplines
Excellent requirements and specification writing skills
Demonstrated deep understanding of US and international regulatory requirements for a heavily regulated product
Ability to build and maintain effective cross-functional and cross-organizational relationships
Excellent oral, written and presentation skills
In depth knowledge performing risk management per ISO 14971
In depth knowledge in developing and testing products to IEC60601-1 Safety standard
In depth knowledge in developing and testing products to IEC62336 EMC standard
Automation & Systems Engineer in N2P Messaging Team handling AWS environment and Jenkins pipelines for Net2Phone. Responsibilities include cloud networking, infrastructure as code, and systems maintenance.
Staff Collaboration Systems Engineer managing Google Workspace for Pinterest. Leading technical authority and mentoring in collaboration platform solutions.
Contract Systems Analyst at Sunshine Enterprise managing PeopleSoft Financials and HCM systems. Implementing, upgrading, and supporting enterprise applications, ensuring data integrity and business operations continuity.
Structural Systems Engineer specializing in structural analysis of aerospace vehicle pressurized systems. Involving design, development, and execution of test programs for launch and space structures.
Systems Engineer at Quevera collaborating with experts to deliver innovative solutions. Join our dynamic team recognized as a top employer in the Baltimore/DC area.
Staff Systems Engineer working on delivering complex software applications into operations with a talented team at CACI. Supporting development and verification of mission capabilities while ensuring operational efficiency.
Senior Systems Engineer supporting mission - critical software and AI/ML product development. Collaborating within an Agile team to transition complex systems to operational use.
IT Support Specialist ensuring installation, support, and maintenance of IT systems in healthcare settings. Focusing on efficiency, stability, and customer service with a team - oriented approach.
RF Systems Engineer III developing spacecraft communication systems for civil, commercial, and National Security Space programs. Collaborating with cross - functional teams to enhance RF communications technology.
Systems Engineer supporting deployment and operational reliability in cloud - based healthcare platform. Collaborate with engineering and QA teams to manage cloud environments and troubleshoot issues.