As a member of the Quality Engineering team, this engineer will liaison closely with R&D, Supplier Quality, Operations Engineering, and Receiving Inspection to ensure open and timely communication of pipeline project deliverables including but not limited to material specifications, drawings, fixture requirements, Gage Repeatability & Reproducibility Studies, First Article Inspections, inspection procedures, inspection methods, and sampling plans.
Essential Duties and Responsibilities:
- Provide the primary input to the design, development and implementation of fixtures for measuring component parts in Receiving Inspection.
- Attend assigned design control and phase exit meetings on behalf of Quality Engineering.
- Work closely with Receiving Inspection, Project Quality Engineers, and Supplier Quality Engineers to develop and implement inspection methods, sampling plans, and related procedures.
- Provide direct and ongoing support to Receiving Inspection in evaluating inspection methods, process improvements, sampling plans, coordination of first article component and fixture inspections, selection and qualification of inspection equipment.
- Create vision system CMM programs to semi-automatically measure complex molded component parts and sub-assemblies
- Develop inspection processes for complex and high volume component throughput
- Create and conduct measurement capability assessments (eg Gage Repeatability and Reproducibility)
- Design and develop methods to determine measurement accuracy and precision through testing and analysis
- Evaluate and determine cause for measurement variation
- Create test strategies and conduct process/equipment/measurement method qualifications and validations
- Provide key support in the design and fabrication of mechanical fixtures, tooling, and equipment for component/sub-assembly measurement
- Work closely with Supplier Development, Research & Development, Quality and other support groups and departments
- Measure task/project percentage completion at critical stages and takes appropriate actions as needed to keep tasks/projects on track
- Independently plan, manage and prioritizes tasks/projects, tracks progress toward overall goals, and provides periodic updates to management
- Typically requires a Bachelors’ degree in Mechanical Engineering, Manufacturing Engineering, or related field with 5+ years of relevant industry experience and/or training.
- Proven ability to work hands-on in a fast-paced environment
- Proficiency with inspection equipment such as: CMM (Mitutoyo Vision and Touch Probe System, OGP vision System, digital microscopes, and other), is desired.
- Proficiency with engineering software tools for CAD (SolidWorks preferred), engineering analysis, and statistical analysis (e.g. Minitab)
- Proficiency with Microsoft Office Products
- Proficiency with basic statistical analysis (normality, standard deviation, variance, and comparison of data groups) including Gage R&R and test method validations.
- Proficiency in inspection equipment and fixture design, development and implementation
- Previous direct involvement in medical device industry or a regulated industry
- Ability to run self-directed projects, maintain timelines, transfer technology and execute projects in an R&D and GMP manufacturing environment
- Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things.
- Strong interpersonal and teamwork skills
- Demonstrated written and verbal communication skills
- Proficient with geometric dimensioning and tolerancing and the ability to read mechanical drawings.
- Certified Quality Engineer and LeanSix SigmaBlack Belt certifications are a plus