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Position Overview

The Manufacturing Engineer II is responsible for providing engineering support to Production. Also responsible for designing, developing, testing, and implementing processes, tooling, and fixtures for commercial product. In addition, will sustain activities on the production line such as raw material, process and equipment issues.

Essential Job Functions

• Actively collaborate with Production to provide sustaining support in resolving product/process problems.
• Actively identify and participate in process/product, tooling, equipment, fixtures and cost reduction improvement projects.
• Coordinate and/ or perform functional and destructive testing of product for process validation or new supplier qualifications. Document the results and provide a statistical analysis using Minitab or excel.
• Participate as an extended team member for new product introduction.
• Participate in development and maintenance of process FMEAs, Manufacturing Process Instructions (MPIs), and Device Master Record (DMR) documents.
• Create and release label files used for printing product labels.
• Create and execute process validation protocols and reports.
• Create and maintain documentation for product configurations (e.g., bills-of-materials), and other Quality System requirements.
• Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.

Requirements

• Bachelor’s degree in engineering.
• 3-5 years of experience in a medical device environment.
• Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations.
• Understanding of Lean and Six Sigma concepts.
• Experience with Validation of Medical Devices (IQ-OQ-PQ).
• Basic understanding of Statistics (Cpk, Hypothesis Testing, DOE’s, Gage R& R) a plus.
• Able to create Solids and Drawings in SolidWorks.
• Ability to work in a fast-paced environment while managing multiple priorities.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• Employee may be required to lift objects up to 25lbs or more. Employees will be required to work in an air-conditioned office space.
• This position will be required to travel at least 50% of the time.