Principal Reliability Engineer

Medtronic

Hybrid

Quick summary

Work type: Hybrid
Location: Billerica, MA
Salary: $149,500–$187,200 / yr
Posted: 49 days ago
Closes: Jun 30, 2026
Nearby: 99+ roles within 25 mi

Market check

Salary context

Competitive pay

How this pay compares to similar roles

Similar $185k

This role $168k

$134k most similar roles pay here $233k

This role pays less than 66% of similar roles. Most pay $150,084–$219,343 — the shaded band above. At the midpoint, this role pays about $168k versus about $185k for comparable roles.

Based on 240 similar postings.

Employer

About Medtronic

Medtronic plc is the world's largest medical technology company by revenue, specializing in device-based therapies for over 70 health conditions.

Medtronic currently has 70 open roles on FindRole.

Listed pay typically runs $124,800–$187,200 across 68 roles with salary data.

Most-posted roles

View all roles at Medtronic

At a glance

TL;DR · Principal Reliability Engineer

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Principal Reliability Engineer at Medtronic in Billerica, MA, is a senior-level role focusing on ensuring the quality and regulatory compliance of medical products through design control and risk management. This position involves updating risk management documents, conducting root cause analysis, and supporting various regulatory audits while adhering to standards like FDA 21 CFR Part 820 and ISO guidelines. The engineer will coordinate Corrective & Preventive Actions (CAPA) programs, apply Lean Six Sigma methodologies, and perform statistical analyses using tools such as Design of Experiments (DOE). Daily tasks include executing development protocols like IQ/OQ/PQ and TMV for capital equipment and single-use devices. Candidates must have a Master’s degree in Mechanical or Biomedical Engineering along with extensive experience in quality engineering and manufacturing processes.

Skills

Root_Cause_Analysis FDA_21_CFR_Part_820 ISO_14971 ISO_13485 ISO_9001 ISO_10012 ISO_17025 Lean_Six_Sigma GMP GDP CAPA Risk_Analysis FMEA Verification_and_Validation Design_of_Experiments Statistical_Analysis Installation_Qualification Operational_Qualification Performance_Qualification Test_Method_Validations Capital_Equipment_Design Single_Use_Device_Design

What you'll do

Ensure compliance with FDA 21 CFR Part 820, ISO standards, and GMP regulations.
Conduct risk management updates for medical products based on post-market surveillance.
Support regulatory audits by preparing quality system process documents and records.
Coordinate Corrective & Preventive Actions (CAPA) programs and Lean Six Sigma initiatives.
Execute Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).
Utilize Design of Experiments (DOE) for product development and manufacturing engineering.

What we're looking for

Master’s degree in Mechanical or Biomedical Engineering with 5+ years of quality or manufacturing engineering experience.
Expertise in FDA regulations, ISO standards (14971, 13485, 9001), and supporting regulatory audits for Quality system process documents.
Proficient in Lean Six Sigma, GMP, GDP, CAPA programs, and risk analysis including FMEA, V&V, DOE, statistical analysis.
Experience with Mechanical GD&T, RCA, IQ/OQ/PQ protocols, Test Method Validations (TMV), and design controls for medical devices.
Ability to coordinate Corrective & Preventive Actions (CAPA) programs and execute methodical problem-solving in product design and manufacturing.

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