Principal System Design Engineer

Voto Consulting LLC; Arden Hills (MN); Hybrid; USD 180,000 - 230,000; Full time

Benefits offered by this job

Hybrid work arrangement

Potential conversion to FTE

Job summary

Voto Consulting LLC is seeking a Principal System Design Engineer for a hybrid 12-month contract with potential conversion to full-time. The role focuses on developing electronic medical equipment systems, collaborating with global teams and managing system architecture across software and hardware domains.

Ideal candidates have 15+ years in IT/medical device systems engineering, strong leadership, and deep experience with design controls, requirements management, and regulatory compliance.

Qualifications

• Extensive system engineering experience in medical devices and Class II/III programs.
• Strong leadership and cross-functional collaboration across global teams.
• Experience with design controls, requirements traceability, and regulatory standards.
• Proven ability to drive system architecture, interfaces, and risk management.
• Proficiency with requirements management and PLM tools (DOORS, Windchill, JAMA).
• Willingness to travel up to 10% to client divisions and clinics.

Responsibilities

• Direct the technical team to define system architecture and oversee both physical and functional designs.
• Provide system-level integration of hardware and software from global sources.
• Collaborate across projects to deliver system architecture, design, integration, and testing.
• Identify and address system issues using modeling, analysis, and testing.
• Oversee project progress, report status, and support timely issue resolution.
• Mentor engineers and contribute to leadership decisions and process improvements.

Skills

System architecture

Leadership

Cross-functional collaboration

Regulatory awareness

Agile/ Scrum

Communication

Problem solving

Education

Bachelor's degree in engineering or related field

MS/PhD preferred

Tools

JAMA

DOORS

Cognition COCKPIT

JIRA

Windchill

SysML/Arcadia/UML/OPM

Job description

Job Title: Principal System Design Engineer

End Client: Develops medical products and technologies used to diagnose and treat medical conditions.

Term: 12 Month Contract (Potential for conversion to FTE)

Process: 01 Virtual Interview

Job Description

• This is going to be a hybrid 12 Month contract role with potential for conversion to FTE.
• Selected candidate would work hybrid out of the client's Arden Hills office which is just north of downtown Minneapolis.
• For this specific requisition, we're looking for an Individual Contributor as high-level as possible, someone who truly checks off all the boxes (15+ years overall IT experience, Medical Background, Full Tech Stack, Certifications, Leadership, Communications etc.)

About the role

• Our end client develops medical products and technologies used to diagnose and treat conditions such as heart, digestive, pulmonary, vascular, urological, pelvic health, and chronic pain issues.
• They lead in advancing medical solutions globally and continue to expand into new regions and markets.
• System Design Engineers will be part of the global system design team to develop new Electronic Medical Equipment (EME) systems, working with multidisciplinary engineers across all the relevant divisions.
• This role focuses on driving new product development.

Key Responsibilities

• Direct the technical team in defining system architecture, managing interfaces, and overseeing both physical and functional designs.
• Provide system-level expertise for integrating hardware and software from global sources while supporting collaboration and decision-making with internal and external teams.
• Collaborate with peers to design and deliver technical solutions across various projects, including but not limited to system architecture, system design, implementation, integration, and testing for complex, connected electronic medical equipment systems and systems-of-systems in accordance with end client’s product development procedures.
• Identify and address system issues using simulation, mathematical analysis, characterization and system interaction testing, and provide recommendations for corrective actions.
• Oversee technical project progress by troubleshooting, communicating status to stakeholders, and supporting timely resolution.
• Guide process improvements within systems engineering and contribute to AI-driven patient management and healthcare solutions.
• Facilitate safety and security analyses to ensure compliance and risk mitigation.
• Mentor engineers by sharing best practices and domain knowledge and provide technical input for leadership decisions.
• Make ongoing adjustments to processes and methodologies through collaboration with peers and cross functional groups, analyzing activities to enhance workflow and work processes.
• Manage third party designers, vendors, and contractors to deliver engineering solutions efficiently.
• Demonstrate practical understanding of project management concepts and experience with Agile methodologies, including scrums.

Basic Qualifications

• Degree in mechanical, electrical, computer science, systems engineering, or a related field.
• 15+ years of experience with a bachelor’s degree, or 08+ years with a master’s or 04+ years with Ph.D., in medical device systems engineering and leading complex Class II/III programs.
• Proficient in requirement management tools like JAMA, DOORS, Cognition COCKPIT and product lifecycle tools like JIRA, Windchill.
• Expert in medical device design controls, including user needs, intended use, system requirements, design, and requirements traceability.
• Proven leadership in cross-functional teams, stakeholder alignment, and balancing technical and business goals.
• Successful record in developing system/product requirements, verification/validation, and regulatory compliance for global markets.
• Effective collaborator in fast-paced, global environments.
• Up to 10% travel to end client’s divisions and clinics.

Preferred Qualifications

• Possesses an MS, Ph.D. or equivalent advanced business leadership training in Systems Engineering, Electrical Engineering, Software Engineering, or a related discipline.
• Holds INCOSE CSEP (International Council on Systems Engineering Certified Systems Engineering Professional) certification or an equivalent professional credential.
• Experienced in system modeling languages, including SysML, Arcadia, UML, OPM, or comparable frameworks.
• Recognized for leadership through awards or significant contributions to innovation, cross-functional collaboration, and process optimization within systems engineering.
• Demonstrates expertise in risk management and DFMEA, with a proven ability to identify and implement effective risk controls.
• Proficient in cybersecurity design principles, with hands‑on experience specifying and facilitating their integration.
• Successfully led project teams on high-impact, high-priority technological initiatives.
• Familiar with quality systems and experienced with IEC and ISO standards pertaining to the medical device software lifecycle and risk management (specifically IEC 62304).
• Proven track record of strong cross-functional collaboration, influence without formal authority, and project management that foster highly effective project teams.
• Self‑motivated individuals who proactively address critical issues, ambiguous requirements, and loosely defined challenges, consistently mobilizing teams to deliver business outcomes.
• Demonstrated ability to quickly learn new platforms and development environments to align with evolving project objectives.
• Excellent verbal, written, and interpersonal communication capabilities, with a history of effective problem resolution.
• Highly developed communication and time management skills.
• Extensive experience collaborating with global, distributed teams.