QA Design Transfer Engineer I/II - Medical Devices

Merit Medical Systems, Inc.; Pearland (TX); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Multiple Shifts

Medical/Dental Insurance

Onsite Medical Clinic

Onsite Cafeterias

Vacation/Sick/Holidays

401K & HSA

Job summary

Merit Medical Systems, Inc. is seeking an engineering professional to support design transfer and manufacturing for medical devices.

You will participate in risk assessments, validate processes, and drive continuous quality improvements across product lines. The role requires a Bachelor's degree in Engineering, strong knowledge of medical device standards, and experience with quality tools (Minitab, Six Sigma) for root cause analysis and problem solving.

Qualifications

• Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field.
• Working knowledge of 21 CFR 820, ISO 13485, ISO14791 and other medical device standards.
• Experience with statistical methods, quality control tools, problem solving and project management.
• Knowledge of regulatory agency regulations.
• Computer skills including spreadsheets, word processing and databases.

Responsibilities

• Participates in design and development activities and transfers outputs into manufacturing.
• Leads risk management analyses and documents results; drives mitigations.
• Reviews and generates ECNs to update verification, validation, and inspection methods.
• Performs studies to solve complex technical problems and drive improvements.
• Engages in quality system compliance, containment of nonconforming product, and data analysis.

Skills

21 CFR 820

ISO 13485

ISO14791

Quality control

Root cause analysis

Lean manufacturing

Six Sigma

Problem solving

Minitab

Oracle

Education

Bachelor's degree in Engineering

Job description

Merit Medical Systems, Inc. is seeking an engineering professional to support design transfer and manufacturing for medical devices.

You will participate in risk assessments, validate processes, and drive continuous quality improvements across product lines. The role requires a Bachelor's degree in Engineering, strong knowledge of medical device standards, and experience with quality tools (Minitab, Six Sigma) for root cause analysis and problem solving.