Senior Medical Device Quality Engineer - Design for Reliability

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

Benefits offered by this job

Health Insurance

Dental and vision insurance

Health Savings Account

Healthcare Flexible Spending Account

Life insurance

Long-term disability leave

Dependent daycare spending account

Tuition assistance/reimbursement

Simple Steps (global well-being plan)

Incentive plans

401(k) with employer match

Short-term disability

Paid time off

Paid holidays

Employee Stock Purchase Plan

Employee Assistance Program

Non-qualified Retirement Plan Support

Capital Accumulation Plan

Job summary

Regulatory Jobs in Memphis, TN seeks an experienced engineer to develop and evaluate medical device designs optimized for manufacturability, reliability, and cost. You will verify design functionality, apply DMAIC and DRM, and ensure FDA/ISO regulatory compliance across design, testing, and documentation.

Responsibilities include risk assessment with FMEA, QMS processes, CAPA/RCA, and maintaining PSURs, CERs, and TD files per EU MDR and global requirements.

Qualifications

• Requires a Master’s degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field.
• Minimum 2 years of experience as a quality, product or validation engineer.
• Experience with DMAIC, FMEA, ISO 14971, FDA 21 CFR Part 820, ISO 13485, GDP.
• Strong knowledge of QMS, CTQ, and GMP requirements.
• Proficiency with Minitab, DOE, SPC, ANOVA, t-tests, regression analysis, and process capability.
• Familiarity with CAPA, RCA, IQ/OQ/PQ, PSUR, CER, and EU MDR.
• Experience with PPAP, CP, PF, and MR for transfer projects.

Responsibilities

• Develop and evaluate designs meeting medical device requirements and manufacturability goals.
• Verify design functionality with test method development and specifications.
• Apply DMAIC, DRM, and lean tools in line with FDA regulations and ISO standards.
• Collaborate with cross‑functional teams to maintain regulatory documentation.
• Lead CAPA and RCA activities to prevent recurrence and document resolutions.
• Prepare PSURs, CERs, and TD files per EU MDR and global requirements.

Skills

DMAIC methodology

Minitab

DOE

SPC

Gage R&R

ANOVA

T-test

Regression analysis

Process capability

Confidence & tolerance

FMEA

A3 thinking

PDCA

Ishikawa

QMS

CTQ

FDA 21 CFR 820

ISO 13485

GDP

IQ/OQ/PQ

CAPA

RCA

PSUR

CER

TD files

PPAP

CP

PF

MR

Education

Master's degree in Mechanical/Industrial/Biomedical Engineering

Job description

Regulatory Jobs in Memphis, TN seeks an experienced engineer to develop and evaluate medical device designs optimized for manufacturability, reliability, and cost. You will verify design functionality, apply DMAIC and DRM, and ensure FDA/ISO regulatory compliance across design, testing, and documentation.

Responsibilities include risk assessment with FMEA, QMS processes, CAPA/RCA, and maintaining PSURs, CERs, and TD files per EU MDR and global requirements.