Systems Engineer

Role Summary

Systems Engineer responsible for the accurate and compliant management of Design History Files (DHFs) for medical devices or combination products throughout their lifecycle within the scope of systems engineering. Ensures DHF documentation adheres to regulatory standards and company procedures, supporting product development, design changes, regulatory submissions, and audit readiness.

Responsibilities

• DHF Management:
  • Supports the maintenance of Design History Files (DHFs) for on-market products. (Design Inputs, Design Validation, Trace Matrix)
  • Ensures complete and accurate traceability of DHF documentation, including design plans, inputs, outputs, verification and validation records, risk management files, and design change documentation.
  • Collaborates with cross-functional teams to gather, impact assess and incorporate necessary changes into the DHF.
• Regulatory Compliance:
  • Supports regulatory submissions by ensuring well-maintained and audit-ready DHFs, including ensuring conformance to the latest recognized consensus standards and timely closure of assigned change plan action items.
  • May participate in regulatory inspections and audits, providing DHF documentation as requested.
• Documentation and Review:
  • Identify and address any gaps or discrepancies within the DHF.
  • Supports the creation and maintenance of traceability matrices, ensuring links between design elements are clearly documented.
• Process Improvement:
  • Identifies and recommends improvements to DHF documentation processes and procedures.
  • May participate in DHF remediation activities.

Qualifications

• Education: Bachelor's degree in engineering, physical sciences, or a related field.
• Experience: 2+ years of experience in the medical device or pharmaceutical industry, with a focus on Design Controls including marketed product support DHF change control.
• Technical Skills:
  • Basic understanding of medical device or combination product development processes and change control.
  • Proficiency in Design History File creation, maintenance, and organization.
  • Proficiency in DHF impact assessment.
  • Familiarity with regulatory requirements and standards (e.g., FDA 21 CFR 820.30, ISO 13485, ISO 14971)
  • Experience with risk management activities, requirement definition, Design Verification, and Design Validation processes.
  • Experience with Document Management Systems (DMS) or Electronic Quality Management Systems (eQMS) is preferred.

Preferred Qualifications

• Experience with TrackWise, Polarion

Skills

• Regulatory knowledge and compliance mindset
• Documentation and record-keeping excellence
• Cross-functional collaboration
• Attention to detail and problem-solving

Education

• Bachelor's degree in engineering, physical sciences, or related field

Additional Requirements

• Physical Job Requirements: This position is in an office environment. Work primarily entails working at a computer, reading and/or writing (~95%). Travel: Not specified.