Medical Device Manufacturing Engineer

Position: Medical Device Manufacturing Engineer

Location: Plymouth, MN

Key Responsibilities:

Lead the design, development, and optimization of manufacturing processes for medical devices.

Collaborate with R&D teams to transition new products from design to manufacturing.

Ensure compliance with FDA regulations (21 CFR 820) and ISO 13485 standards.

Develop and implement process validation and qualification plans.

Perform root cause analysis for process issues and implement corrective actions.

Support production teams by troubleshooting and resolving process-related problems.

Conduct risk assessments and ensure compliance with safety and quality standards.

Create and update technical documentation, including process flows, work instructions, and SOPs.

Drive continuous improvement initiatives to enhance efficiency, cost-effectiveness, and quality.

Monitor key performance indicators (KPIs) to track and improve manufacturing performance.

Qualifications:

Bachelor's degree in Engineering, Biomedical Engineering, or a related field.

5+ years of experience in medical device manufacturing engineering.

Strong knowledge of medical device regulatory requirements (FDA, ISO 13485).

Proven experience in process development, validation, and optimization.

Strong problem-solving and analytical skills.

Ability to work cross-functionally with different departments (R&D, QA, Operations).

Excellent communication and project management skills.

Proficient in CAD software (SolidWorks, AutoCAD, etc.) and ERP systems.