Process Reliability Engineer

Job Description

A Process Reliability Engineer ensures that manufacturing processes are robust, reliable, and compliant with applicable ISO standards, regulatory requirements, and internal quality systems. The role involves analyzing field and customer data, executing incoming, in‑process, and outgoing quality checks, and supporting reliability testing and environmental qualification to ensure product reliability throughout the lifecycle.

Principal Duties and Responsibilities
Develop, review, and revise manufacturing processes and process‑reliability–related procedures.

Ensure effective implementation, control, and maintenance of records related to engineering changes, process qualifications, investigations, and corrective and preventive actions for process and reliability matters.

Cross‑Functional Collaboration
Partner closely with manufacturing, R&D, field operations, marketing, and global quality teams to ensure timely execution of changes, new product introduction and process risk reduction (PFMEA)

Field and Customer Quality Support
Monitor, track, and provide timely updates on assigned field and customer feedback and quality issues (e.g., defect on arrival).
Drive part return analysis, investigations, root cause analysis (RCA), and corrective and preventive actions to ensure effective and sustainable issue closure.

Data Collection and Analysis
Collect and analyze quality and reliability data using appropriate statistical and analytical tools to support quality improvement initiatives and risk mitigation.

Continuous Improvement
Identify opportunities for process and reliability improvements, recommend corrective actions, and oversee their effective implementation.

Process Validation, Reliability & Qualification
Apply strong knowledge of process validation, instrument qualification, and reliability testing methodologies to support product quality and compliance.
Review manufacturing part qualification risk assessment and test plan development related to Safety, EMC, and Environment/Stress Testing requirements.

Training and Knowledge Sharing
Participate in process and reliability quality training programs by developing, updating, and delivering training materials for new and existing employees. May mentor junior engineers and QC staff.

Audit and Regulatory Support
Act as Process Subject Matter Expert (SME) or provide backroom support during internal and external quality audits led by the Quality Assurance team.

Qualifications

• Educational Background: A Bachelor’s or Master’s Degree, or an equivalent university qualification.
• Experience Requirement: A minimum of 5 years of relevant professional experience.
• Knowledge of Quality Standards: Familiarity with Quality System Standards such as ISO 9001:2015, ISO 13485:2016, FDA CFR 21 Part 820, IEC 61010, ISO17025:2025 as well as regulations related to In Vitro Diagnostics (IVD) and Medical Devices in the EU/US; familiarity with EMC and CSA safety compliance is an added advantage.
• Data Analysis Skills: Proficient in data analysis, statistical tools, manufacturing reliability engineering, and process validation (IQ/OQ/PQ), with strong capability in root cause analysis, problem-solving, and continuous improvement (CI).
• Language Proficiency: Fluent in English, with strong writing and verbal communication skills.

Additional Details

This job has a full time weekly schedule.

Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.

Travel Required:

No

Shift:

Day

Duration:

No End Date

Job Function:

Manufacturing