NPI Test Development Engineer

Diality; Irvine (CA); On-site; USD 104,000 - 120,000; Full time

Job summary

Diality, a medical device company based in Irvine, CA, seeks a Test Development Engineer to join their NPI team. This pivotal role involves designing and implementing test solutions to ensure product quality and reliability within a regulated environment. The ideal candidate will leverage their technical skills in a collaborative setting to impact the development of innovative dialysis solutions.

Qualifications

• 5+ years of experience in test development or test engineering, preferably in a production setting.
• Experience working in a regulated medical device industry.

Responsibilities

• Design and develop production test systems for product verification.
• Analyze test data to identify trends and drive improvements.
• Provide technical support to manufacturing and operations teams.

Skills

Problem-solving skills

Attention to detail

Test method analysis

Documentation skills

Understanding of verification practices

Communication

Education

Bachelor’s degree in mechanical engineering, biomedical engineering, or a related field

Tools

LabVIEW

Python

Job description

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Base pay range

$104,000.00/yr - $120,000.00/yr

Direct message the job poster from Diality

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.

We are seeking a highly motivated Test Development Engineer to join our NPI (Operations) team. The ideal candidate will be responsible for designing, developing, implementing, and supporting test solutions for manufacturing and operational processes. This includes automated test systems, diagnostics, calibration and verification tools to ensure the quality and reliability of products during production.

Responsibilities

• Design and develop production test systems (hardware and software) for product verification and validation.
• Collaborate with design, quality, manufacturing and vendors to define test requirements and ensure test coverage.
• Implement automated test solutions to improve efficiency, accuracy, and scalability in production environments.
• Develop and maintain test fixtures, scripts, and infrastructure.
• Analyze test data and identify trends, root causes, and corrective actions to drive yield improvements.
• Provide technical support to manufacturing and operations teams to resolve test-related issues.
• Maintain and calibrate test equipment, ensuring compliance with industry standards and internal policies.
• Document all test procedures, specifications, and results in line with quality management systems.
• Perform Gauge R & R and IQ/OQ/PQ for custom test fixtures.
• Develop and perform design of experiments .
• Develop strategies and detailed test plans to ensure product performance.

Required Skills & Abilities

• Experience within a highly regulated medical device industry.
• Hands-on experience with electronic measurement instruments (e.g., oscilloscopes, multimeters, power supplies).
• Strong problem-solving skills and attention to detail.
• Proficient in test method analysis and test method validation
• Good documentation skills with strong communication and teamwork abilities.
• Demonstrated ability to work on problems of a complex scope where analysis of situations or data involves multiple competing factors.
• Solid understanding of verification and testing best practices
• Experience working closely with vendors and contract manufacturers
• Familiarity with medical device test standards a plus .
• Experience with test automation a plus .

Education & Experience

• Bachelor’s degree in mechanical engineering, biomedical engineering, or a related field.
• 5+ years of experience in test development or test engineering, preferably in a production or operations setting
• Working knowledge in test software environments such as LabVIEW and/or Python preferred
• Experience in executing verification/testing software in a design and production environment

Physical Requirements

• Standing for periods of time
• Lifting equipment’s up to 40 lbs.

Travel

• Up to 10%

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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