Senior Systems Engineer

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Contact Shawn Recker at srecker@saigepartners.com or 319-804-9996 to learn more about this opportunity!

Position Summary:

The Senior Systems Engineer position is a key technical leadership role with responsibility for the design ownership of a single product throughout its full lifecycle. In this role, you will integrate multi-disciplinary inputs and outputs to support the definition and development of complex software-controlled electro-mechanical medical device products. As the design owner, you will ensure that the product is built in accordance with customer, business, and regulatory requirements. This includes effectively translating product requirements to design outputs, managing technical risks, and aligning with the technology roadmap.
This position overlaps various technical and human-centered disciplines, including industrial engineering, functional engineering, human factors, marketing, regulatory affairs, quality assurance, and project management. A strong candidate will demonstrate a keen ability to facilitate cross-functional collaboration. The Senior Systems Engineer will lead technical planning, systems integration, verification and validation, cost and risk management, lifecycle management, and overall effectiveness for total systems.

Primary Duties and Responsibilities:

• Ensure the logical and systematic translation of user and project needs into a comprehensive set of system and sub-system requirements in collaboration with technical design leaders.
• Take technical ownership of the product throughout its lifecycle and provide effective technical leadership to the product and engineering teams.
• Resolve technical challenges by providing guidance to the team through rigorous trade-off analysis to create robust and effective solutions.
• Facilitate cross-functional decision-making and balance technical and schedule risks with cost targets for lifecycle needs.
• Lead the integration of sub-systems to ensure the product meets user and system requirements, demonstrating traceability through validation and verification.
• Own risk, hazard, and timeline analysis to evaluate design concepts quantitatively.
• Plan, coordinate, and manage cross-functional design activities and interface with product leadership on project issues and status.
• Integrate sound design principles, including Design for Reliability, Manufacturing, and Service.
• Identify user groups, environments, scenarios, and critical tasks for task analysis, instructions, user training, and system verification.
• Collaborate with test teams to ensure the success of verification and validation activities.
• Lead activities such as Failure Modes and Effects Analysis (FMEA) to identify design issues and develop mitigations.
• Support the creation of high-quality documentation, including design specifications, test plans, project schedules, and change orders.
• Partner with functional technical leaders to develop impactful Intellectual Property that drives business growth.
• Adhere to and promote the quality standards and processes defined by the organization.
• Ensure product compliance with FDA, UL, CE, and other governing body requirements as defined by product management.
• Foster a culture of continuous improvement.

Minimum Qualifications:

• Bachelor’s degree in Engineering or a related scientific discipline (preferably systems, electrical, mechanical, or software engineering).
• 5–8 years of engineering experience.
• 3–5 years of experience in new product development with exposure to systems engineering roles.
• Demonstrated experience with risk management and systems engineering processes.
• Strong ability to translate needs and requirements into actionable plans.
• Excellent interpersonal, organizational, and communication skills.
• High attention to detail with the ability to handle multiple tasks and prioritize effectively.
• Ability to work independently and collaboratively as part of a team.
• Proven ability to develop protocols, conduct system tests, and produce detailed reports.
• High energy, initiative, and passion for new technologies.

Preferred Qualifications:

• Graduate degree in Engineering (EE, ME, SW) or related scientific discipline.
• 5+ years of systems engineering experience.
• Experience working with physicians and customers in a medical device development role.
• Knowledge of finite element analysis, tolerance analysis, and geometric tolerance.
• Awareness of system-level constraints across disciplines, including mechanical, electrical, and software.
• Experience with voice-of-customer methodologies and familiarity with clinical radiology terminology.

Additional Information:

• Adherence to all company policies, procedures, and ethical standards.
• Ability to travel up to 10% of the time.

Saige Partners, one of the fastest-growing technology and talent companies in the Midwest, believes in building Careers, Not Jobs. We are passionate about helping professionals succeed and fostering a thriving company culture. Contact us to learn more about this opportunity or explore other opportunities at https://careers.saigepartners.com/.