Senior Systems Validation Engineer

4 weeks ago

Irvine, California, United States DIALITY INC Full time
Job Title: Senior Systems Validation Engineer

Join Daliity Inc, a leading medical device company, in the development of a revolutionary smart hemodialysis machine. As a Senior Systems Validation Engineer, you will play a critical role in ensuring the safety and effectiveness of our products.

Responsibilities:
  • Lead human factors research and design activities to validate product performance in real-world settings.
  • Collaborate with cross-functional teams to design studies that accurately reflect clinical environments and workflows.
  • Collect and analyze data to validate the safety and effectiveness of products in clinical use.
  • Document findings and provide recommendations for design improvements based on clinical use validation results.
  • Communicate user needs and insights to cross-functional teams to inform design decisions.
  • Ensure all human factors engineering activities comply with FDA Human Factors Engineering Guidance.
  • Conduct formative and summative evaluations as specified by FDA human factors guidelines to identify and mitigate potential use errors.
  • Create detailed human factors engineering reports to support FDA submissions, including use-related risk analyses, validation test protocols, and test results.
  • Collaborate with regulatory affairs teams to ensure all human factors documentation meets FDA requirements.
  • Collaborate with product designers, engineers, and other stakeholders to incorporate human factors principles into the design process.
  • Create and maintain documentation for human factors activities, including user profiles, task analyses, use scenarios, and risk assessments.
  • Responsible for coordinating with functional and cross-functional team members to ensure project milestones are achieved.
  • Share knowledge, best practices, and lessons learned from previous experiences to cultivate a culture of learning and excellence within the engineering team.
Qualifications & Requirements:
  • Bachelor's or Master's degree in Human Factors Engineering, Bioengineering, Industrial Engineering, or a related field.
  • Minimum of 5-7 years of experience in human factors engineering, preferably in medical devices.
  • Proven track record of leading human factors activities in product development cycles.
  • Expert knowledge of human factors standards and guidelines (e.g. FDA Human Factors Guidance, IEC 62366, HE75).
  • Expert knowledge on medical device regulations and standards (e.g., FDA QSR, ISO 13485, ISO 60601, ISO 14971), providing guidance on interpretation and implementation to ensure compliance.
  • Proficiency in human factors and usability testing tools and methodologies.
  • Experience with user interface design and evaluation.
  • Excellent communication and interpersonal skills, with the ability to effectively collaborate with diverse teams and stakeholders at all levels of the organization.
  • Proven ability to drive results and meet project timelines and milestones while maintaining high standards of quality and compliance.
  • Experience in risk management methodologies (e.g., Use FMEA) and their application to medical device development and regulatory compliance.
  • Experience in user need and human factors engineering for medical device systems is a plus.
Working Environment:
  • Typical office areas with offices, cubicles and conference rooms. Typical laboratory and chemical storage areas which may contain hazardous compounds requiring adherence to safe handling practices.
Travel:
  • Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences.

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