Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

Functional Domain: Product Failure Analysis & Root Cause Determination
• Perform analysis of the product to assess product performance and support investigation activities.
• Identify, evaluate, and document technical findings from product and field data.
• Support troubleshooting and root cause investigations by integrating information from multiple data sources.
• Collaborate with cross-functional partners to provide analysis-based insights and recommendations.
• Prepare clear and concise documentation, summaries, and reports of analysis outputs.
• Recognize trends and recurring issues to support product quality and continuous improvement efforts.
• Ensure analysis activities are executed in accordance with established procedures, quality standards, and regulatory requirements.

Responsibilities may include the following and other duties may be assigned:

• Review of software logs relevant to complaint analysis
• Review of service reports relevant to complaint analysis
• Review of image filmables (non-implantable) relevant to complaint analysis.
• Software Telemetry & Log Diagnostics: Interrogating, parsing, and analyzing device-generated software logs and error codes to map anomalous behavioral events relevant to reported product complaints.
• Field Service Engineering Evaluations: Reviewing and interpreting field service records, preventive maintenance logs, and on-site technician reports for non-implantable eqpt to identify failure modes.
• Diagnostic Imaging Analysis: Evaluating product performance anomalies through the review of clinical imaging data, film, or device-captured media to corroborate field failure reports.
• Technical Service Infrastructure Failures: Investigating systemic or localized failure trends identified within technical service channels to determine component-level or systemic vulnerabilities.
• Any other tasks assigned.

Required knowledge and experience: 

• Bachelor’s degree in engineering, Science, or Technical Discipline required and  5-8 years of experience.
• To handle the complexity of system-level failures, diagnostic logs, and medical regulatory standards, you should target:
• Education: Bachelor’s degree in Bio-Medical Engineering, Electronics & Communication Engineering, Computer Science / Software Engineering, or a closely related technical field.
• Experience Range:
  • Mid-Level (Individual Contributor): 3 to 6 years of experience in product failure analysis, post-market surveillance engineering, or systems troubleshooting.
  • A proven track record of leading complex root-cause investigations.
• Industry Background: High preference for Medical Devices (specifically active medical devices/capital equipment), Healthcare IT, or highly regulated industries with complex electromechanical/software systems (e.g., Aerospace, Automotive).

Technical Knowledge & Core Competencies

The ideal candidate must possess a strong blend of data systems and hardware/software troubleshooting skills.

Software Log Diagnostics & Telemetry (Critical)

• Strong proficiency in reading, parsing, and interpreting software logs, error codes, and system events to reconstruct a failure timeline.
• Familiarity with software/hardware communication protocols.

 Medical Systems & Imaging Domain Knowledge

• Basic understanding of medical imaging standards (e.g., DICOM format, PACS systems) to review and evaluate image files or device-captured media.
• Experience reviewing and interpreting Field Service Reports (FSRs) and preventive maintenance records for medical capital equipment.
• Familiarity with clinical environments or hospital-based technical infrastructure (e.g., how non-implantable equipment interacts with hospital networks).

Root Cause Investigation & Quality Engineering

• Practical knowledge of established Root Cause Analysis (RCA) methodologies: 5 Whys, Fishbone (Ishikawa) diagrams, FMEA (Failure Mode and Effects Analysis), and FTA (Fault Tree Analysis).
• Experience using CAPA (Corrective and Preventive Action) frameworks to drive continuous product improvement.
• Ability to synthesize insights from diverse data streams (software logs + technician text reports + imaging files) to form a cohesive technical conclusion.

Regulatory & Compliance Standards

Because post-market complaint analysis is heavily audited, the candidate must understand:

• Thorough understanding of ISO 13485 (Medical Devices — Quality Management Systems).
• Familiarity with FDA 21 CFR Part 820 (Quality System Regulation) and post-market surveillance/complaint handling guidelines.
• Experience working within a highly structured Quality Management System (QMS).

Soft Skills & Professional Attributes

• Analytical Mindset: Excellent pattern-recognition skills to spot emerging, systemic failure trends before they escalate.
• Cross-Functional Communication: Ability to translate complex software log anomalies and technical jargon into clear, actionable insights for R&D, Quality Assurance, and Field Service teams.
• Technical Writing: Exceptional written communication skills for drafting rigorous, audit-ready technical investigation reports.

• Good communication skills, both oral and written.
• Comfortable working with international and multi-cultural departments and groups in different time zones.
• Timely & accurate delivery quality work.
• Ability to work well under pressure and maintain positive, enthusiastic attitude.
• Ability to work in a fast-paced environment.
• Eagerness to learn and expand responsibilities.
• Medical Device Vigilance & Complaint Management: Demonstrated expertise in post-market surveillance and complaint handling workflows within a regulated medical device environment (governed by FDA 21 CFR Part 820.198 and ISO 13485 standards).
• Advanced Technical Documentation: Proficient in technical writing with a proven track record of authoring comprehensive complaint investigation summaries, root cause analyses & regulatory-compliant narrative reports.
• Cross-Functional System Diagnostics: Strong technical acumen in diagnosing complex, multi-tiered medical device architectures across software logs, hardware components, firmware interactions, and electro-mechanical sub-assemblies.
• End-to-End Investigation Lifecycle Ownership: Competency in defining critical technical task protocols, performing structured product failure analyses, and synthesizing empirical findings into definitive engineering and final investigation closures.
• Stakeholder Communication: Exceptional verbal & written communication skills, with the ability to articulate technical risk, root cause hypotheses & engineering data clearly to cross-functional and quality assurance leadership.
  Nice to Have:
• Good interpersonal skills.
• Previous experience working with global team (Aerospace, Defense, Med device, automobile preferably).
• Exposure to FDA Quality System Regulation & ISO 13485 standard.
• Working knowledge of Standard, Guidance, and Regulations.
• Lean Six Sigma Yellow belt /Green Belt.

 

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. 

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If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com. 

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Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

 

 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).