Medical Device Manufacturing Engineer — Data-Driven GMP/ISO

TechDigital Group; Santa Clara (CA); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a skilled engineer with expertise in medical device manufacturing. This role involves drafting protocols, generating reports, and developing test methods while ensuring compliance with FDA and GMP guidelines. The ideal candidate will possess strong analytical skills and experience with statistical software, CAD tools, and various inspection methods. Join a dynamic team where your contributions will directly impact the quality and safety of medical devices, making a difference in people's lives. If you are passionate about engineering and have a knack for problem-solving, this opportunity is perfect for you.

Qualifications

• 3-5 years of engineering experience in medical device manufacturing.
• Knowledge of FDA and GMP guidelines is essential.

Responsibilities

• Draft protocols and generate reports including data analysis.
• Develop and validate test methods in a medical device environment.

Skills

Data Analysis

Test Method Development

Statistical Software (Minitab, JMP)

Six Sigma

Solidworks

FDA Guidelines

Good Manufacturing Practice (GMP)

ISO Guidelines

Inspection Tools

Technical Writing

Communication Skills

Education

Bachelor's degree in Mechanical Engineering

Tools

Solidworks

Minitab

JMP

MS Project

Job description

An established industry player is seeking a skilled engineer with expertise in medical device manufacturing. This role involves drafting protocols, generating reports, and developing test methods while ensuring compliance with FDA and GMP guidelines. The ideal candidate will possess strong analytical skills and experience with statistical software, CAD tools, and various inspection methods. Join a dynamic team where your contributions will directly impact the quality and safety of medical devices, making a difference in people's lives. If you are passionate about engineering and have a knack for problem-solving, this opportunity is perfect for you.