Senior Systems Engineer

Insight Global; Houston (TX); On-site; USD 96,000 - 124,000; Full time

Job summary

Insight Global is seeking a Senior Systems Engineer to support the development and commercialization of complex medical devices in Houston, onsite. You will coordinate across hardware, software, electrical, mechanical, quality and regulatory teams to ensure integrated system performance, safety and regulatory compliance.

The role involves translating user needs into system requirements, defining architecture, and maintaining traceability through design verification and validation, with hands-on

Qualifications

• Hands-on experience developing and managing system-level requirements.
• Translating user needs into system and subsystem requirements and defining interfaces.
• Experience with system architecture for hardware/software/electrical/mechanical products.
• Familiarity with ISO 14971 and risk-control measures and design-control environments.

Responsibilities

• Translate user needs into system requirements and maintain traceability through V&V.
• Define system architecture and interfaces across hardware, software, electrical and mechanical.
• Develop verification strategies and support testing activities and reports.
• Investigate defects, non-conformances, CAPAs and design changes; support change control.
• Collaborate across software, electrical, mechanical, quality, regulatory and testing teams to drive decisions.

Skills

Systems engineering

Requirements traceability

Risk management

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in Systems Engineering

Job description

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

Skills and Requirements

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

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [e-mail].