Senior Design Quality Engineer — Medical Device (DMAIC, FDA)

Medtronic; Memphis (TN); On-site; USD 115,000 - 148,000; Full time

Benefits offered by this job

Health, Dental and Vision insurance

Health Savings Account

Healthcare Flexible Spending Account

Life insurance

Long-term disability leave

Tuition assistance/reimbursement

Simple Steps well-being program

Incentive plans

401(k) with employer match

Employee Stock Purchase Plan

Paid time off

Paid holidays

Capital Accumulation Plan

Job summary

Medtronic in Memphis, TN seeks a Mechanical/Industrial/Biomedical Engineer to design and evaluate medical device products for manufacturability, reliability, and cost. You will verify performance with test methods and apply DMAIC and DRM while following FDA and ISO 13485 requirements.

Collaborating across functions on regulatory documentation, risk management (FMEA), CAPA, PSUR and CER, you will drive design improvements using Minitab, DOE and MS Project.

Qualifications

• Master’s degree in Mechanical, Industrial, or Biomedical Engineering.
• 2 years of experience as a quality, product or validation engineer.
• Experience with DMAIC, Minitab, DOE, SPC, FMEA and ISO 14971.
• Familiarity with FDA 21 CFR Part 820, ISO 13485 and GDP.
• IQ/OQ/PQ, CAPA and RCA knowledge.
• PSUR, CER and TD file preparation per EU MDR.

Responsibilities

• Develop and evaluate designs meeting defined medical device requirements.
• Verify design functionality with test methods and specs.
• Ensure compliance with FDA, ISO, GDP and QMS processes.
• Collaborate with cross-functional teams on regulatory documentation.
• Lead DMAIC/DRM projects to improve manufacturability and cost.

Skills

DMAIC methodology

FMEA

PDCA

Ishikawa (Fishbone)

A3 thinking

CAPA

RCA

QMS processes

Education

Master's degree in Mechanical, Industrial, or Biomedical Engineering

Tools

Minitab

MS Project

Job description

Medtronic in Memphis, TN seeks a Mechanical/Industrial/Biomedical Engineer to design and evaluate medical device products for manufacturability, reliability, and cost. You will verify performance with test methods and apply DMAIC and DRM while following FDA and ISO 13485 requirements.

Collaborating across functions on regulatory documentation, risk management (FMEA), CAPA, PSUR and CER, you will drive design improvements using Minitab, DOE and MS Project.