Position Details

Salary $91K – $147K USD / year

Type Full-Time

Experience mid

Exp. Years 2+ years

Education Bachelor of Science or equivalent university degree in Computer Science or related field; advanced degree preferred

Category Engineering (Non-Software)

About this role

Failure Analysis Engineer responsible for cross-functional root cause investigations of medical device failures; design and execute experiments, analyze logs, and report findings; support regulatory readiness and quality systems in a San Jose setting.

Key Responsibilities

Collaborate with Engineers, Clinical Specialists, Field Service Engineers, and Manufacturing to facilitate deep understanding of device functionality and failures and to perform in-depth root cause analysis
Design and execute experiments and test methods to test theories to refine failure modes and determine root causes
Acquire, analyze, and interpret information from data logs and various applications as part of root cause analysis
Write formal analysis reports, resulting in clear and accurate messaging about analysis findings for a broad audience
Provide frequent verbal and written updates of work-in-progress for various meetings

Technical Overview

Focus on root cause analysis techniques, data log analysis, and regulated environment compliance (ISO 13485, ISO 14971, GMP); engage cross-functional teams and mentors as needed.

Ideal Candidate

The ideal candidate is a mid-level failure analysis engineer with 2+ years of industry experience in a regulated medical-device environment, strong root cause analysis skills (FMEA, Hazard Analysis, 5 whys), and knowledge of ISO 13485/14971 and GMP; capable of communicating findings and working with cross-functional teams.

Must-Have Skills

2+ years of proven industry experienceAt least 1 year in a regulated environment (medical deviceaerospace/defenseor similarly regulated industry)At least 1+ years of experience conducting Failure Investigation/Analysis in an engineering environmentExperience with data logs applications and other test tools in support of failure analysisProficiency in root cause analysis tools and techniques (Hazard AnalysisFMEAFault TreePareto diagramscause-and-effect diagrams5 whys)Experience with trend analysisParetoand other basic charting techniquesStrong communicationpresentation and interpersonal skillsExperience with ISO 13485 and 14971GMPFDA regulationsAbility to travel up to 10%

Nice-to-Have Skills

Demonstrated knowledge across software engineeringSix-SigmaASQ CQEor similar certifications

Required Skills

Bachelor of Science in Computer Science or related field; 2+ years experience; root cause analysishazard analysisFMEAfault treePareto diagramscause-and-effect diagrams5 whys; data logs; ISO 13485; ISO 14971; GMP; 6-Sigma; ASQ CQE

Hard Skills

Computer ScienceRoot cause analysisHazard AnalysisFMEAFault TreePareto diagramscause-and-effect diagrams5 whysdata logsdata analysisISO 13485ISO 14971GMP6-SigmaASQ CQERegulated environment

Soft Skills

Outstanding communicationPresentation skillsInterpersonal skillsAnalytical reasoningTeamwork

Certifications

Preferred

Six-SigmaASQ CQE

Industry & Role

Industry Healthcare & Medical

Job Function Quality Engineering / Failure analysis for Johnson & Johnson MedTech

Role Subtype Quality Engineer

Keywords for Your Resume

Failure Analysis Engineerroot cause analysisHazard AnalysisFMEAFault TreePareto diagramscause-and-effect diagrams5 whysdata logsmedical deviceISO 13485ISO 14971GMPSix-SigmaASQ CQEregulated environmentdata analysiscommunication skillsbachelor of science in computer science

Deal Breakers

Lack of 2+ years experience, No experience in a regulated environment, No familiarity with root cause tools (FMEA, Hazard Analysis, etc.)

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