RCI-ZB-37118716 System Designer/DHF (design history file)/SaMD/ISO 14971/IEC 62366/Codebeamer, Jira

Schedule Notes: Time Zone: Mountain Time

Remote

Job Description:

• The ideal candidate will have a solid background in medical device design controls and product development, with direct experience in regulatory compliance and documentation.
• You’ll play a key role in refining existing documentation and ensuring continued regulatory alignment to support new and existing products.
• Candidates must have experience with software as a medical device (SaMD).

Requirements

• 5 years of experience
• Strong Experience with Software as a Medical Device (SaMD)
• Strong experience in design controls in a multi-disciplinary organization.
• Experience drafting and maintaining DHF (design history file) content, including user needs, design inputs, design outputs, traceability matrices, and risk documentation.
• Able to support risk analysis (e.g. uFMEA, etc.) and contribute to usability planning and design mitigations.
• Familiarity with ISO 14971 is required, and IEC 62366 preferred.
• Ability to define testable requirements, support V&V protocol development, and ensure traceability in collaboration with the Product Development team.
• Strong collaboration skills across R&D, QA, clinical, and regulatory functions; able to clearly translate technical information across stakeholders.
• Must have experience in a regulatory environment with strict compliance.
• Strong analytical skills and accurate judgment-making skills.
• Ability to deal effectively with internal and external collaborators.
• Excellent communications skills; written and verbal.
• Experience with Codebeamer, Jira, or similar.

Duties and Responsibilities

System Design

• Define the design approach, ensuring alignment with product objectives, user needs, clinical workflows, and system performance.
• Translate user needs and system requirements into practical design solutions.
• Lead design discussions and technical reviews, evaluating alternatives and trade-offs.
• Ensure design decisions address usability, risk mitigation, technical feasibility, and long-term product sustainability.

System Testing

• Implement and review product verification and validation (V&V) testing, including developing protocols, test methods, and performance specifications.
• Perform manual and automated testing and document results accurately.

Product Documentation

• Collaborate with QA, Service, Compliance, and Regulatory teams to meet documentation requirements and ensure cross-functional alignment.
• Create, review, and maintain risk management files, including cybersecurity risks.
• Ensure all product requirements are documented, traceable to verifiable tests, and kept up-to-date.
• Ensure compliance with FDA, ISO, and internal design controls.
• Maintain the Design History File (DHF) to be complete, accurate, and regulatory-compliant, addressing gaps proactively.

Education Requirements

• Bachelor’s degree in engineering or science related field; biomedical engineering preferred.

Career page link: https://talentarbor.com/job/details/137751/3/560/system-designer-warsaw-in-us