Lead Systems Validation Engineer

2 months ago

Irvine, California, United States Diality Full time

Job Title

Senior Systems (Validation) Engineer

Department

Systems Engineering

Hiring Manager Title

Associate Director of Systems Engineering

Position Type

Exempt

Company Overview:

Diality Inc is a dedicated medical device firm focused on enhancing the lives of individuals with kidney conditions. Our innovative approach involves the development of a portable hemodialysis machine designed for patient self-treatment, whether at home or on the go. This adaptable solution aims to empower patients to receive their tailored dialysis prescriptions in various environments, including healthcare facilities, without reliance on pre-prepared dialysate bags or complex water treatment systems.

Role Overview:

The Senior Systems Validation Engineer will be pivotal in guaranteeing that our products are user-friendly, safe, and effective. This role involves leading research and design initiatives centered on human factors, collaborating with diverse teams, and applying user-centered design methodologies to shape product development from initial concept to final production. Your extensive knowledge will be essential in directing the design and validation of intricate systems, ensuring adherence to regulatory standards and industry best practices.

Key Responsibilities:

  • Plan and implement validation studies to evaluate product performance in real-world clinical settings.
  • Collaborate with clinical partners to design studies that accurately represent clinical workflows.
  • Gather and analyze data to confirm the safety and efficacy of products in actual use.
  • Document findings and recommend design enhancements based on validation outcomes.
  • Communicate user insights to cross-functional teams to guide design choices.
  • Ensure compliance with FDA Human Factors Engineering Guidance in all engineering activities.
  • Conduct evaluations as per FDA guidelines to identify and mitigate potential user errors.
  • Create comprehensive reports to support regulatory submissions, including risk analyses and validation protocols.
  • Work with regulatory teams to ensure all documentation meets necessary requirements.
  • Engage with product designers and engineers to integrate human factors principles into the design process.
  • Maintain thorough documentation of human factors activities, including user profiles and risk assessments.
  • Coordinate with team members to ensure project milestones are met.
  • Share knowledge and best practices to foster a culture of continuous improvement within the engineering team.

Qualifications:

  • Bachelor's or Master's degree in Human Factors Engineering, Bioengineering, Industrial Engineering, or a related discipline.
  • 5-7 years of experience in human factors engineering, ideally within the medical device sector.
  • Demonstrated success in leading human factors initiatives throughout product development cycles.
  • In-depth knowledge of human factors standards and guidelines.
  • Expertise in medical device regulations and standards, providing guidance on compliance.
  • Proficiency in human factors testing methodologies.
  • Experience in user interface design and evaluation.
  • Strong communication and interpersonal skills for effective collaboration.
  • Proven ability to achieve results while adhering to project timelines and quality standards.
  • Experience in risk management methodologies relevant to medical device development.
  • Familiarity with user needs and human factors engineering for medical device systems is advantageous.

Physical Demands:

  • Ability to stand and sit for extended periods in a laboratory environment.
  • Proficient in using a computer for prolonged durations.
  • Occasional lifting of items weighing less than 25 pounds.

Working Environment:

Standard office settings with cubicles and meeting rooms, alongside laboratory areas that may contain hazardous materials requiring adherence to safety protocols.

Travel Requirements:

Willingness to travel domestically as necessary, primarily for vendor visits and select conferences.

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