Reliability Engineer II

The Reliability Engineer II is an individual contributor with deep expertise in electrical engineering, software development principles, and project management. This role executes complex investigations and projects, adapting traditional approaches to develop innovative solutions. The position is responsible for maintaining programs for systematic monitoring and evaluation of product reliability and quality standards, ensuring compliance with regulatory and internal requirements.

This is an onsite opportunity based out of Alameda, CA.

What You'll Work On

• Perform detailed failure analysis investigations on returned ADC products (readers and sensors), including hardware and embedded software components.
• Lead and support medium-sized projects, applying project management methodologies to ensure timely completion.
• Collaborate with cross-functional teams to address recurring reliability issues in both hardware and software domains.
• Conduct sustaining activities such as process improvements, tooling updates, and software reliability enhancements.
• Apply quality principles and perform complex analysis of quality records and reports to recommend improvements.
• Document reliability issues and performance measures for management review.
• Provide technical guidance to engineers in the lab and mentor on best practices for hardware/software integration.
• Liaise with external vendors and internal design teams to resolve technical challenges.

Required Qualifications

• Bachelor's degree in a technical (e.g. electrical/mechanical/software) or scientific (e.g. statistics/math) discipline.
• Or an equivalent combination of education and work experience
• Equivalent experiences is defined as five years in a role responsible for product engineering, ideally in a medical device industry.
• Experience in product failure analysis, hardware/software integration, and reliability investigations.
• Experience supporting CAPA activities and nonconforming product/procedure investigations
• Knowledge of embedded systems, and electrical design principles.
• Excellent problem-solving and critical thinking skills.
• Ability to manage complex technical investigations and adapt solutions.
• Project management and organizational skills, with the ability to manage multiple priorities and meet deadlines.
• Strong technical writing and presentation skills, including the preparation of investigation reports and the communications of findings to management and stakeholders

Preferred Qualifications

• Knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485.
• Proficiency with data analysis and statistical tools (e.g., Power BI, Python) to evaluate reliability trends, identify patterns, and determine root causes.
• Experience with Failure Modes and Effects Analysis (FMEA) and Root Cause Analysis (RCA) methodologies, including 5 Whys and Fishbone analysis.
• Demonstrated ability to work effectively within cross-functional teams, including Quality Assurance, R&D, and Manufacturing.