Key skills
RJiraRisk ManagementCollaboration
About this role
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).
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.
Skills: 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.
Keywords:
Education: Education Requirements
Bachelor's degree in engineering or science related field; biomedical engineering preferred.
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.
Skills: 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.
Keywords:
Education: Education Requirements
Bachelor's degree in engineering or science related field; biomedical engineering preferred.