Clinical Validation Engineer

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.
• Plan and conduct clinical validation studies to inform clinical workflows and UX design.
• 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.
• Provide clinical workflow and harm assessment as part of the risk management process (SHA, DFMEAs)
• Provide assessments on clinical workflows on prototypes and action design changes.
• Collaborate with regulatory affairs and human factors engineering team to ensure all human factors documentation meets FDA requirements.
• 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

Requirements

• Proven track record of leading clinical validation and user validation studies in product development cycles.
• Experience in clinical workflows of hemodialysis systems or related medical device systems
• Knowledge of medical device regulations and standards (e.g., FDA QSR, ISO 13485, ISO 60601, ISO 14971), providing guidance on interpretation and implementation to ensure compliance.
• 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 user clinical validation, preferably in medical devices, is a plus (e.g. FDA Human Factors Guidance, IEC 62366, HE75)
• A certified dialysis technician and/or dialysis nurse is a plus

Qualifications

• Bachelor’s or master’s degree in Life Sciences, Human Factors Engineering, Bioengineering, Industrial Engineering, or a related field.
• Minimum of 3-5 years of experience in user clinical validation, preferably in medical devices.

Skills

• Experience in clinical workflows of hemodialysis systems or related medical device systems
• Knowledge of medical device regulations and standards (e.g., FDA QSR, ISO 13485, ISO 60601, ISO 14971), providing guidance on interpretation and implementation to ensure compliance.
• 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 user clinical validation, preferably in medical devices, is a plus (e.g. FDA Human Factors Guidance, IEC 62366, HE75)
• A certified dialysis technician and/or dialysis nurse is a plus

Benefits

• Sustained periods of time standing and sitting in a laboratory
• Sitting at a desk utilizing a computer
• Some lifting of

Pay

• Competitive salary commensurate with experience

Schedule

• Full-time