Manufacturing Engineer (Medical Device)

Overview

Title:

Manufacturing Engineer – Medical Devices Location:

Arizona We are looking for a

Manufacturing Engineer

to support medical device production operations. This role ensures efficient processes, compliance with regulatory standards, and continuous improvement to deliver high-quality products.

Responsibilities

Support daily manufacturing operations and resolve technical issues.

Develop, validate, and optimize manufacturing processes and equipment.

Collaborate with R&D, Quality, and Supply Chain on new product transfers.

Maintain process documentation (SOPs, work instructions, validations).

Ensure compliance with

FDA, ISO 13485, and GMP

standards.

Support audits, CAPA, and operator training.

Qualifications

Bachelor’s degree in Engineering (Mechanical, Biomedical, or related).

2–5 years of experience in medical device or regulated manufacturing.

Knowledge of

ISO 13485, FDA 21 CFR Part 820, validation, and GMP .

Strong problem-solving and cross-functional collaboration skills.

CAD/ERP/MES experience is a plus.

Employment type:

Contract

Seniority level:

Mid-Senior level

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