NPI Test Development Engineer

ZipRecruiter; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Diality Inc, a leading medical device company, is seeking a highly motivated Test Development Engineer in Irvine, CA. This role involves designing and implementing test solutions for manufacturing processes, ensuring product quality and reliability, and collaborating with various teams within the organization. The ideal candidate will have a robust background in the medical device industry, hands-on experience with testing instruments, and a degree in a relevant engineering field.

Qualifications

• 5+ years of experience in test development or test engineering.
• Experience within a highly regulated medical device industry.
• Working knowledge in test software environments.

Responsibilities

• Design and develop production test systems for product verification.
• Collaborate to define test requirements and ensure test coverage.
• Analyze test data and identify trends for yield improvements.

Skills

Problem-solving

Attention to detail

Test method analysis

Test method validation

Documentation

Teamwork

Education

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

Tools

LabVIEW

Python

Electronic measurement instruments

Job description

Job DescriptionJob Description

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.

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.
• Participate in design transfer activities.
• 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
• 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%