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.