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Job Details

Skills

Human Factors Engineering (HFE)
Design Controls
Usability Engineering
Risk Analysis
Risk Remediation
Task Analysis
Polarion
Medical Device Regulations (MDR / FDA / IEC 62366 / AAMI HE75)
Traceability
Agile PLM / Document Control

Summary

Job title: Human Factors Design Controls Engineer

Location : Remote

Duration : 1 year

Job Description:

Primary Function of Position

As part of the Human Factors team, the Human Factors Design Controls Engineer works closely with fellow Human Factors team members, department leadership, and cross-functional partners. The Human Factors Design Controls Engineer is a key contributor responsible for informing, guiding the development of, and maintaining usability engineering documentation produced during product development projects. Responsibilities are focused on the comprehensive and timely implementation of task analysis and related risk analysis documentation.

This role supports the Human Factors Engineering team with expertise in design controls and content creation using tools such as Polarion and document control software (e.g., Agile). The engineer helps create usability engineering documentation required for submission to global medical device regulatory agencies.

This role provides dedicated support and subject matter expertise to the broader Human Factors Engineering team across multiple business units and reports to a Human Factors Team Lead.

Roles and Responsibilities

Support remediation of usability-related risk analysis documentation, including revising, editing, reformatting, collating, and tracing task analysis and usability risk analysis document content.
Support the definition, release, and maintenance of usability-related design input documentation.
Create and maintain traceability documentation within the Polarion tracing environment.
Identify and resolve tracing conflicts and design input orphans between risks, design inputs, and risk controls.
Collaborate with Human Factors engineers, Quality, Regulatory, Systems Engineering, and cross-functional teams to ensure design control documentation is accurate and compliant.
Maintain documentation in document control systems such as Agile and other digital collaboration tools.
Ensure usability engineering documentation aligns with medical device regulatory requirements and internal design control processes.
Participate in documentation reviews, change management activities, and risk remediation efforts.
Provide guidance and support to Human Factors Engineering teams regarding design controls, traceability, and usability documentation best practices.
Work remotely using company-issued laptop, software, and administrative systems.

Required Qualifications

Education

Bachelor's degree in Human Factors Engineering, Biomedical Science, Biomedical Engineering, Systems Engineering, Quality Engineering, Information and Data Science, Cognitive Psychology, Computer Science (with Human-Computer Interaction emphasis), Human-Centered Design, or a related field.

Experience

Minimum 5 years of related experience with a bachelor's degree in engineering or a related discipline.
Hands-on experience with design controls, risk remediation, and risk analysis in medical device product development or a related regulated industry.
Experience working with digital project collaboration and document management tools such as:

Polarion
Agile
Smartsheet
Similar lifecycle/document control platforms

Technical Knowledge

Strong understanding of medical device regulations and Human Factors best practices, including:

MDR (Medical Device Regulation)
IEC 62366
AAMI HE75
FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices

Experience creating and maintaining usability engineering documentation.
Knowledge of traceability, design inputs, risk controls, and usability risk management documentation.

Soft Skills

Excellent verbal and written communication skills.
Strong presentation and documentation skills.
Ability to work effectively in a highly collaborative, cross-functional environment.
Comfortable communicating through multiple channels, including email, instant messaging, video conferencing, and collaborative platforms.
Strong organizational skills with attention to detail and documentation accuracy.
Ability to manage multiple priorities while meeting project timelines.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10511336
Position Id: 9039450
Posted 3 days ago

Fitment

Dice Job Match Score™

🛠️ Calibrating flux capacitors...

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Andrew Fugle

Della Infotech Recruiter @ Della Infotech

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Human Factors Design Controls Engineer

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Andrew Fugle

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