Development Quality Engineer

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

Job Details: Job Location: Saint Paul, MN 55127 Salary Range: $80,000.00 - $120,000.00 Salary/year Job Shift: Days Job Category: Engineering

Summary: Primary duties are to provide quality engineering support of the Development/NPI team at Innovize. This includes the support and documentation of validation activities, ensuring compliance to industry and regulatory standards, development and qualification of measurement methods, and supporting the implementation and qualification of new product lines. The engineer should be comfortable working within a team, have strong attention to detail, and be able to accommodate multiple projects simultaneously.

Duties / Responsibilities

• Lead root cause analysis of manufacturing process issues encountered during the development cycle
• Facilitate the creation of process failure mode and effects analysis
• Author process flow charts, master validation plans, process qualification protocols and reports, test plans, process failure modes and effects analyses, sampling strategies, test method validation protocols and reports, work instructions, control plans
• Assist inspection associates in the creation of receiving inspection instructions
• Represent quality team in project meetings and completing assigned tasks on time
• Capability analysis of process, test, and qualification data

Competencies / Talents / Personal Attributes

• Communicates effectively
• Ability to present information to all levels within the organization
• Strong math skills with ability to understand descriptive and inferential statistics.
• Ability to read blueprints, recognize UL specifications and understand geometric dimensioning and tolerancing (GD&T).
• Demonstrates a basic understanding of ISO 13485 and GMP requirements.
• Ability to understand material characteristics, tooling specifications, equipment, and how materials, tooling, and process settings interact to affect the overall tolerance capability of various product designs.
• Ability to balance the requirement for meeting customer expectations and FDA regulations with company profitability in supporting the Quality Technician in developing estimates for work and inspection instructions.
• Excellent attention to detail.
• Basic understanding and application of SixSigma (DMAIC) manufacturing concepts and Lean concepts.
• Ability to determine appropriate inspection tools to be used i.e. fixtures, templates, coordinate measuring machine, and go-no go gauges, etc.
• Ability to create and sustain effective relationships both internally and externally.

Qualifications

• Four-year Bachelor of Science/Engineering degree
• Alternatively, a demonstrable 10-years of progressively responsible work experience in a technical manufacturing Quality role supporting Quality Engineering
• Or a two-year technical degree and demonstrable 6-years of progressively responsible work experience in a technical manufacturing Quality role supporting Quality Engineering
• 2 years of medical manufacturing experience (may include internship experience)
• Experience in an automated manufacturing and testing environment. Rotary converting a plus.
• Proficient PC skills in MiniTab and Microsoft Office.
• CAD modelling experience preferrable.
• Able to utilize GD&T software packages highly desirable.
• Engineering experience in medical device contract manufacturing.