Systems Engineer- Med Device
Systems Engineer
Position Summary
We are looking for a systems-minded engineer with exceptional attention to detail to serve as the final checkpoint for all Systems Engineering deliverables. This role is responsible for ensuring technical documentation meets the highest standards of clarity, traceability, and compliance with design control requirements. The ideal candidate brings a collaborative spirit, a sharp eye for quality, and a growth-oriented mindset-even when feedback isn't always adopted.
Key Responsibilities
• Review and validate Systems Engineering outputs, including requirements documents, trace matrices, risk files, and verification protocols
• Ensure alignment with 21 CFR 820.30, ISO 13485, and internal design control processes
• Verify that system-level requirements are clearly defined and traceable throughout the design history file
• Identify and resolve content inconsistencies, gaps, or ambiguities prior to document release
• Apply and maintain document standards, templates, and formatting best practices
• Support Quality Management System submissions by preparing documentation for audit and regulatory readiness
Minimum Qualifications
• Bachelor's degree in Systems Engineering, Biomedical Engineering, or a related field
• Advanced degree preferred
• Interest in learning and applying design control frameworks and documentation standards
• Strong written and verbal communication skills
• Highly organized with effective time management
• Comfortable working both independently and cross-functionally
Preferred Attributes
• Accuracy and efficiency in document review and technical editing
• Collaborative approach to feedback and team objectives
• Maintains engagement and professionalism regardless of implementation outcomes
• Invested in personal growth and continuous learning within systems engineering and quality disciplines
• Demonstrates ownership and provides sound rationale for technical input
Supervisory Responsibilities
• None
Collaboration
• Cross-functional engineering and quality teams
Work Environment and Conditions
• Frequent use of computer, telephone, and standard office equipment
• Occasional extended hours during high-volume periods
• May include light lifting
• Limited travel as required
Apply Now
Apply Now
Position Summary
We are looking for a systems-minded engineer with exceptional attention to detail to serve as the final checkpoint for all Systems Engineering deliverables. This role is responsible for ensuring technical documentation meets the highest standards of clarity, traceability, and compliance with design control requirements. The ideal candidate brings a collaborative spirit, a sharp eye for quality, and a growth-oriented mindset-even when feedback isn't always adopted.
Key Responsibilities
• Review and validate Systems Engineering outputs, including requirements documents, trace matrices, risk files, and verification protocols
• Ensure alignment with 21 CFR 820.30, ISO 13485, and internal design control processes
• Verify that system-level requirements are clearly defined and traceable throughout the design history file
• Identify and resolve content inconsistencies, gaps, or ambiguities prior to document release
• Apply and maintain document standards, templates, and formatting best practices
• Support Quality Management System submissions by preparing documentation for audit and regulatory readiness
Minimum Qualifications
• Bachelor's degree in Systems Engineering, Biomedical Engineering, or a related field
• Advanced degree preferred
• Interest in learning and applying design control frameworks and documentation standards
• Strong written and verbal communication skills
• Highly organized with effective time management
• Comfortable working both independently and cross-functionally
Preferred Attributes
• Accuracy and efficiency in document review and technical editing
• Collaborative approach to feedback and team objectives
• Maintains engagement and professionalism regardless of implementation outcomes
• Invested in personal growth and continuous learning within systems engineering and quality disciplines
• Demonstrates ownership and provides sound rationale for technical input
Supervisory Responsibilities
• None
Collaboration
• Cross-functional engineering and quality teams
Work Environment and Conditions
• Frequent use of computer, telephone, and standard office equipment
• Occasional extended hours during high-volume periods
• May include light lifting
• Limited travel as required
Apply Now
Apply Now