System Engineer

As a Systems Engineer at MGC Diagnostics, you will play a key role in the design and development of cutting-edge cardiorespiratory devices. You will work cross-functionally to bring devices from concept to market. 

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

• Develop system and subsystem requirements based upon user requirements
• Generate test cases for design requirements 
• Lead risk management processes, including generating Hazard Analysis and Design FMEA documentation
• Maintain traceability matrices between requirements, test reports, and risk items
• Ensure device designs meet applicable regulatory requirements
• Work collaboratively with electrical, mechanical, firmware, and software groups to ensure successful subsystem integration
• Participate in design reviews 
• Support the transfer of designs to manufacturing

Competencies/Success Factors 

• Systems Thinking: Ability to understand and model complex systems across hardware and software interfaces
• Analytical Skills: Strong capability to analyze data and identify trends 
• Collaboration: Proven ability to work effectively in cross-functional teams and communicate across disciplines
• Communication: Clear and concise verbal and written communication, including technical documentation and presentations
• Adaptability: Comfortable working in a fast-paced, evolving environment with shifting priorities
• Project Management: Ability to manage tasks, timelines, and deliverables across multiple projects
• Quality Focus: Commitment to product quality, patient safety, and continuous improvement

Supervisory Responsibility

None 

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones and photocopiers.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Frequent standing, sitting, walking, bending, stooping, twisting and occasional crawling.
• Occasional lifting up to 50 lbs., occasional heavier lifting.
• Occasional pushing, pulling and handling of materials.

Travel

Very limited travel, <5%

Required Education and Experience

• Bachelor’s degree in Engineering or related technical discipline
• 3 years of experience in systems engineering or product development in a regulated environment (i.e. medical device, aerospace, automotive, or other safety-critical industries).
• Experience with requirements definition, system architecture, verification, and risk management.
• Working knowledge of systems engineering lifecycle models
• Familiarity with requirements management toolsets.

Preferred Education and Experience

• 5 years of experience specifically in medical device product development
• Hands-on experience integrating hardware, embedded software, and/or thick-client software applications.
• Working knowledge of applicable standards and regulations, such as ISO 13485, ISO 14971, IEC 60601, and IEC 62304.
• Experience with risk analysis tools such as FMEA, FTA, and fault detection/ isolation strategies.
• Experience working in cross-functional, geographically distributed teams.
• Exposure to cybersecurity considerations for connected medical devices (i.e. threat modeling, secure architecture).

Additional Eligibility Qualifications

None required for this position.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

MGC Diagnostics is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.