Haystack
← Back to Jobs
Remote
Engineering

Human Factors Design Controls Engineer

Della InfotechUnited States🇺🇸United StatesPosted 29 Jul 2026

Why This Role Stands Out

This remote role offers a fantastic opportunity to contribute to critical usability documentation for global medical device submissions, leveraging your expertise in design controls. You'll thrive here if you excel at detailed documentation, risk analysis, and collaborating with cross-functional teams to ensure product safety and effectiveness. Apply now to make a significant impact on innovative medical technologies.

Quick Overview

Work Type
Remote
Level
Mid Senior

Job Description

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.

Skills

Agile

Similar jobs

Browse related jobs

Apply now