Development Quality Engineer

Job Details:

Job Location:

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

Summary:

Primary duties are to provide quality engineering support of the Development/NPI team s 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.

• 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

• 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 Six Sigma (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.

• 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 Mini Tab and Microsoft Office.
• CAD modelling experience preferrable.
• Able to utilize GD&T software packages highly desirable.
• Engineering experience in medical device contract manufacturing.