Engineering Associate (Plymouth)

Job Description:

Engineering Associate (Medical Devices) Location :

Plymouth, MN Duration:

12 Months

Position Summary The

Engineering Associate

provides technical support to engineering teams, manufacturing operations, and quality systems. This role bridges the gap between theoretical engineering designs and practical manufacturing execution, ensuring that medical devices are produced efficiently, safely, and in strict compliance with regulatory standards (FDA, ISO 13485).

Key Responsibilities Manufacturing Support:

Troubleshoot production line issues, identify root causes of manufacturing defects, and implement corrective actions to minimize downtime. Documentation & Compliance:

Maintain accurate technical documentation, including Device Master Records (DMR), Standard Operating Procedures (SOPs), and engineering change orders. Process Improvement:

Assist senior engineers in designing, testing, and implementing process improvements to increase yield and reduce costs. Validation Assistance:

Participate in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for new equipment and processes. Quality Control:

Collaborate with Quality Assurance to investigate non-conformances and support Corrective and Preventive Actions (CAPA). Drafting & Design:

Utilize CAD software to create or modify fixtures, tooling, and component drawings.

Required Qualifications Education:

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related technical field. Experience:

0–2 years of experience in a manufacturing environment (internship experience in medical devices or regulated industry is highly preferred). Technical Skills: Proficiency in CAD software (SolidWorks or AutoCAD). Basic understanding of manufacturing processes (molding, machining, assembly). Familiarity with data analysis tools (Excel, Minitab). Regulatory Knowledge:

Fundamental understanding of FDA 21 CFR Part 820 (Quality System Regulation) and ISO 13485.

Core Competencies Attention to Detail:

Meticulous approach to documentation and process adherence. Problem-Solving:

Ability to analyze technical issues and propose practical solutions. Collaboration:

Strong team player able to work across departments (Production, Quality, R&D).