Job Title
Senior Systems (Validation) Engineer
Department
Systems Engineering
Hiring Manager Title
Associate Director of Systems Engineering
Position Type
Exempt
Company & Job Overview:
Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.
The Senior Systems Validation Engineer will play a critical role in ensuring that our products are intuitive, safe, and effective for end-users. This individual will lead human factors research and design activities, collaborate with cross-functional teams, and apply human-centered design principles to influence product development from concept through production. You will leverage your extensive expertise to drive the design and validation of complex systems, ensuring compliance with regulatory standards and industry best practices.
Responsibilities:
Plan and execute clinical use and user need validation studies to assess product performance in real-world settings.
Work closely with clinical partners and stakeholders 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.
Physical Demands:
Sustained periods of time standing and sitting in a laboratory
Sitting at a desk utilizing a computer
Some lifting of<25 pounds
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.