Senior Design Quality Engineer – Medical Devices

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

Benefits offered by this job

Health, dental and vision insurance

401(k) plan plus employer contribution

Employee Stock Purchase Plan

Tuition assistance/reimbursement

Simple Steps global well-being program

Job summary

Medtronic seeks a Mechanical/Industrial/Biomedical engineer to design and evaluate medical devices for manufacturability, reliability, and cost. You will apply DMAIC, DRM, and FDA/ISO requirements, develop test methods, and analyze data with Minitab and DOE. Collaborate across functions to ensure lifecycle management and regulatory compliance.

Experience with PPAP, CAPA, QMS, and risk assessment is expected, along with strong problem-solving and project management skills.

Qualifications

• Master's degree in Mechanical, Industrial, or Biomedical Engineering with 2+ years in quality, product or validation engineering.
• Experience with DMAIC, Minitab, DOE, SPC, and FMEA/ISO 14971.
• QMS, GDP, FDA 21 CFR Part 820, ISO 13485, and GDP familiarity; IQ/OQ/PQ, CAPA and RCA.

Responsibilities

• Develop and evaluate designs meeting medical device requirements and optimize for manufacturability.
• Verify design functionality with test methods and specifications per FDA/ISO.
• Apply project mgmt, Lean sigma, DMAIC & DRM methodologies; use MS Project and data analysis tools.
• Collaborate with cross-functional teams to ensure regulatory documentation and lifecycle management.
• Utilize CAPA, QMS, PPAP, CP, PF, MR processes to drive improvement and risk reduction.

Skills

DMAIC methodology

Lean Sigma

Statistical analysis

Education

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

Tools

MS Project

Minitab

DOE

Job description

Medtronic seeks a Mechanical/Industrial/Biomedical engineer to design and evaluate medical devices for manufacturability, reliability, and cost. You will apply DMAIC, DRM, and FDA/ISO requirements, develop test methods, and analyze data with Minitab and DOE. Collaborate across functions to ensure lifecycle management and regulatory compliance.

Experience with PPAP, CAPA, QMS, and risk assessment is expected, along with strong problem-solving and project management skills.