Required Skills & Experience
Bachelor’s degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Software Engineering, Mechanical Engineering, or a related engineering discipline. Senior-level systems engineering experience supporting the development of complex products, preferably within the medical device industry. Hands-on experience developing and managing system-level requirements, including translating user needs into system and subsystem requirements and defining interfaces between hardware, software, and other components. Experience developing or contributing to system architecture for products that integrate hardware, software, electrical, and/or mechanical components. Strong experience with requirements traceability, including connecting design inputs and outputs to objective verification and validation evidence. Strong knowledge of medical device risk management, including hands-on experience with ISO 14971 and developing or implementing risk-control measures. Experience working within a regulated medical device design-control environment, including familiarity with ISO 13485 and 21 CFR 820.30. Experience developing and executing design verification and validation strategies, including test plans, protocols, execution, and reports. Experience performing system-level technical analysis and design tradeoffs, such as reliability, tolerance, power, error-budget, component, or supplier evaluations. Experience supporting design changes, defect investigations, non-conformances, CAPAs, and change control within a regulated product-development environment. Ability to work cross-functionally with software, electrical, mechanical, quality, regulatory, and testing teams to drive system-level technical decisions. Strong technical documentation and communication skills with the ability to clearly document requirements, risks, technical decisions, and verification evidence
Job Description
We are seeking a Senior Systems Engineer to support the development and commercialization of complex medical devices. This individual will work across hardware, software, electrical, mechanical, quality, and regulatory teams to ensure products are designed as an integrated system and meet performance, safety, quality, and regulatory requirements.
The Senior Systems Engineer will play a key role in translating user needs into system and subsystem requirements, defining system architecture and interfaces, and maintaining requirements throughout the product-development lifecycle. This person will perform technical tradeoff analyses, assess system-level risks, identify appropriate risk controls, and ensure requirements remain traceable through design verification and validation. They will also help develop verification strategies, support execution of testing, and participate in the investigation and resolution of defects, non-conformances, CAPAs, and design changes.
This is a hands-on technical role suited for an experienced engineer who understands how complex hardware/software products come together at the system level and can collaborate effectively across multiple engineering disciplines.
Candidates must be willing to go onsite in Houston, Tx. Pay range: $70-90/hr based on experience