Manufacturing Engineer

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

JD:

1. Experience in drafting protocols & report generation (including Data Analysis)
2. Knowledge in Test method development & Validation.
3. Experience to use of statistical software (ex: Minitab, JMP), six sigma training and/or certification.
4. Experience in Solidworks (or similar CAD software), MS project, basic understanding of FDA, Good Manufacturing Practice (GMP) and ISO guidelines.
5. Familiar with the use of various inspections tools (Ex: pin gauge, caliper, micrometer, snap gauge, drop gauge, block gauge, optical comparator, vision system, etc.)
6. Experience working in a medical device manufacturing environment (Ex: extrusion, injection molding, laser cutting, cleaning, passivation, electropolishing, assembly, bonding, packaging, testing, inspection methods, etc.)
7. Basic understanding of GD&T, tolerance stack up analysis, Statistical Process Control (SPC), fundamentals of Design of Experiments (DOE) and problem-solving methodologies.
8. Good experience in cross-functional interactions & technical writing skills.
9. Good communication skills.

Required Qualifications:

1. Bachelor's degree in Mechanical Engineering, or related discipline or equivalent.

3 to 5 years of significant engineering experience in the medical device field.