Development Quality Engineer for Medical Devices & NPI

Innovize & Xcel Scientific; Saint Paul (MN); On-site; USD 80,000 - 120,000; Full time

Job summary

Innovize & Xcel Scientific in Saint Paul, MN is seeking a Quality Engineer to support the Development/NPI team. The role involves quality engineering support, validation documentation, and ensuring regulatory compliance in a dynamic environment.

Ideal candidates will have a Bachelor of Science/Engineering degree or equivalent experience, demonstrate proficiency in MiniTab and Microsoft Office, and possess strong analytical skills. This position offers the opportunity to impact product quality in the medical device sector.

Qualifications

• Four-year Bachelor of Science/Engineering degree is required.
• 2 years of medical manufacturing experience is preferred.
• Proficient PC skills including MiniTab and Microsoft Office.
• Experience in automated manufacturing and testing environment.

Responsibilities

• Lead root cause analysis of manufacturing process issues.
• Facilitate the creation of process failure modes and effects analysis.
• Author various engineering documents for process and quality.
• Support the Quality Technician in developing work estimates.
• Ensure compliance with industry standards.

Skills

Effective communication

Statistical analysis

Blueprints interpretation

Attention to detail

Understanding ISO 13485

Six Sigma concepts

Interpersonal relationship building

Education

Bachelor of Science/Engineering degree

10 years of work experience in Quality Engineering

Two-year technical degree with 6 years in Quality role

Tools

MiniTab

Microsoft Office

CAD software

Job description

Innovize & Xcel Scientific in Saint Paul, MN is seeking a Quality Engineer to support the Development/NPI team. The role involves quality engineering support, validation documentation, and ensuring regulatory compliance in a dynamic environment.

Ideal candidates will have a Bachelor of Science/Engineering degree or equivalent experience, demonstrate proficiency in MiniTab and Microsoft Office, and possess strong analytical skills. This position offers the opportunity to impact product quality in the medical device sector.