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Manufacturing Engineer II
3 weeks ago
The primary purpose of the Manufacturing Engineer II position is to apply engineering principles to drive process improvements in the manufacturing of medical devices while positively affecting quality, delivery, cost, safety, and morale.
MAIN JOB RESPONSIBILITIES:
- Develops and executes process and test method validations (IQ, OQ, PQ, PPQ) in accordance with company procedures and guidelines.
- Prepares or reviews documentation with a high degree of accuracy, completeness, and effectiveness using common engineering tools and templates. Examples include specifications, manufacturing procedures, Document Change Orders, and technical reports or analysis.
- Creates and implements lean processes in a cellular environment utilizing appropriate methods such as machining, welding, finishing, cleaning, assembly, and inspection.
- Communicates ideas, information, and recommendations clearly, effectively, and frequently within the company, with outside suppliers or partners, and with customers during formal and informal interactions.
- Effectively owns and manages CAPAs pertaining to their areas of responsibility.
- Defines, produces, and implements documents including standard work and process work instructions.
- Creates, reviews, and approves engineering drawings, equipment layouts, change orders, and specifications.
- Develops tooling, fixtures, and equipment used in manufacturing to optimize productivity and cost.
- Creates, schedules, conducts, and/or coordinates detailed project plans for engineering work.
- Applies DMAIC-Six Sigma approaches to solve issues and reduce variation in all manufacturing and business processes.
- Plans and executes project activities within a cross-functional team. Project types can include new product development and introduction, manufacturing transfers, continuous improvement, and cost reduction initiatives.
- Investigates, develops, and implements new process technologies using Lean Manufacturing techniques to continuously improve cycle times and process flows.
- Collaborates with development, programmers, machinists, and suppliers to evaluate designs for manufacturability and cost reduction.
- Demonstrates leadership through mentoring of peers and responsiveness to business needs to achieve positive results.
- Ensures internal and external customer expectations are met or exceeded.
- Creates and executes validation protocols, processes, and material evaluations.
Knowledge/Education:
- Engineering or Bachelors degree in a technical field with applicable experience.
- Demonstrated proficiency in SolidWorks and Minitab.
- Knowledge of PLC programming preferred
Job Experience:
- 2-5 years of experience in a regulated industry.
- Lean manufacturing and new product development or launch support experience is highly desirable.
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