Systems Engineer II Job at Robert Half (Milwaukee)

Systems Engineer II

Robert Half

Location:
United States , Milwaukee

Category:
IT - Software Development

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

We are looking for a Systems Engineer to be responsible for the coordination and management of system design across one or more related product programs. This role supports both new product development and the maintenance of existing products, ensuring alignment with program goals, regulatory requirements, and market needs. The role will partner cross-functionally with Marketing, Sales, Service, Operations, Quality Assurance, and Regulatory Affairs to define requirements, communicate technical direction, and resolve product-related issues throughout the product lifecycle.

Job Responsibility:

Lead the end-to-end product development lifecycle from user needs definition through product launch
Partner with Engineering Project Management to scope and define projects aligned to program goals
Translate market and customer needs into clear, actionable technical requirements
Own and maintain the Design History File (DHF), ensuring completeness and compliance
Develop system-level specifications and ensure proper decomposition into subsystem requirements
Lead risk management activities in accordance with IEC 14971
Ensure usability requirements are addressed in compliance with IEC 62366
Create and manage Verification and Validation (V&V) plans to support product traceability
Ensure traceability between requirements, design, and verification activities
Lead system architecture development, including interface and subsystem specifications
Provide technical leadership to cross-functional development teams
Resolve competing priorities across engineering, manufacturing, regulatory, and commercial teams
Lead system integration efforts and proactively identify and mitigate integration risks
Apply structured problem-solving tools (e.g., root cause analysis, Pareto analysis) to resolve technical issues
Ensure product designs consider manufacturability, serviceability, and performance requirements
Support technical documentation and collaborate with technical writing teams for user-facing materials

Requirements:

Bachelor's degree in Electrical, Mechanical, Software, Biomedical Engineering, or related field (or equivalent experience)
3+ years of experience in systems engineering or product development
Proven experience in system development including requirements and risk management, usability engineering, performance and reliability engineering, and cybersecurity considerations
Hands-on experience with product development tools/methodologies (QFD, Pugh Matrix, CTQ, DFR, DFX)
Experience leading or contributing to system architecture and design efforts
Strong understanding of design controls and documentation (DHF ownership, traceability, V&V)
Excellent communication, leadership, and cross-functional collaboration skills
Strong organizational skills and ability to manage multiple priorities
Ability to work independently and drive tasks to completion with minimal supervision
Proficiency in Microsoft Office tools
Strong problem-solving and analytical skills

Nice to have:

Experience in medical device development (diagnostic cardiology or similar strongly preferred)
Familiarity with industry standards such as IEC 62366 (Usability) and IEC 14971 (Risk Management)
Agile product development experience
Experience with system integration and complex product architectures
Demonstrated ability to influence stakeholders and drive technical decisions
Experience supporting regulatory submissions and quality audits

What we offer:

Medical, vision, dental, and life and disability insurance
Company 401(k) plan
Free online training
Access to top jobs
Competitive compensation

Additional Information:

Job Posted:
May 13, 2026

Work Type:

On-site work

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