How Remoteville checks and expires listings
Human Factors Design Controls Engineer
Skills
Computer ScienceAnalytical SkillsData ScienceMedical DevicesMessaging PlatformsPresentation SkillsProduct Data Management
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- BS in Human Factors Engineering Biomedical Science Engineering Systems Engineering Quality Engineering Information and Data Science Cognitive Psychology Computer Science HCI Human Centered Design or related field
- Minimum 5 years related experience with a bachelor's degree in engineering
- Experience in design controls risk remediation and risk analysis related to medical device product development or related field
- Experience working with digital project collaboration tools such as Polarion Agile PDM or Smartsheets
- Background and understanding of MDR regulations and best practices for medical device human factors including IEC 62366 AAMI HE75 and FDA guidance
- Excellent verbal communication and presentation skills across multiple communication channels
Nice to have
- Detail-oriented
- Cross-functional collaboration
- Regulatory awareness
- Documentation accuracy
- Problem-solving
Day to day
- Supports the Human Factors team by developing and maintaining usability engineering documentation for medical device product development projects.
- Leads task analysis and related risk analysis activities with care, accuracy, and timely execution.
- Collaborates with cross-functional partners to trace design inputs, risks, and controls while resolving conflicts and orphaned records in Polarion.