Senior Engineer: Complaints & Root-Cause Analytics

BioSpace; Thousand Oaks (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Amgen is seeking a Sr. Engineer - Complaints Technical Investigator to conduct technical investigations of advanced complaints linked to product design and usability.

You will own CAPAs from root cause analysis, interact with engineering and quality teams, and mentor staff to improve processes and product reliability. Responsibilities include leading root cause analyses, conducting trend investigations, and generating final reports per procedures.

Qualifications

• Advanced Degree in Science (preferred)
• 10+ years of progressive and relevant experience
• 5+ years in complaints or failure analysis investigations within a development or manufacturing environment (medical devices)
• Proven experience with medical devices
• Six Sigma proficiency for root cause analysis
• ISO 14971 risk management experience (System/User DFMEA/FMEA)
• Experience with protocol and report writing, process/test development and DOE
• Experience leading continuous improvement initiatives
• Strong technical writing and interpersonal skills

Responsibilities

• Lead root cause analysis to identify the failure mode for Amgen products and components due to complaints
• Perform failure analysis using fishbone/5 Whys, FMEAs, Fault Tree Analysis, and tolerance analysis
• Lead cross-functional ideation of design solutions and assess feasibility through testing and analysis
• Perform technical trend investigations and statistical assessments to identify trends
• Support evaluation of returned products, sample inspections, batch records, and review of history/trends
• Generate final investigation reports per established procedures with data analysis
• Develop and perform relational data analytics in investigations
• Advise management on trend and process-improvement opportunities
• Provide input to engineering for product improvements
• Manage, coach and mentor staff; support functional management initiatives

Skills

Root cause analysis

Data analytics

Six Sigma

Technical writing

Interpersonal skills

Risk management

Education

Doctorate degree

Master's degree + 2 years experience

Bachelor's degree + 4 years experience

Associates degree + 8 years experience

High school diploma/GED + 10 years experience

Job description

Amgen is seeking a Sr. Engineer - Complaints Technical Investigator to conduct technical investigations of advanced complaints linked to product design and usability.

You will own CAPAs from root cause analysis, interact with engineering and quality teams, and mentor staff to improve processes and product reliability. Responsibilities include leading root cause analyses, conducting trend investigations, and generating final reports per procedures.