This role supports manufacturing operations in the areas of process development, tool design, machine programming, machinery & equipment acquisition, manufacturing layout, continuous improvement and other duties associated with engineering support of production.
POSITION DUTIES & RESPONSIBILITIES:
* Leads and participates in complex engineering projects, either technically or with an extensive cross-functional team. This includes developing and executing to the plan and schedule and meeting the goals and objectives of the project. Tracks costs, prepares status reports, conducts meetings, and documents and communicates progress to management.
* Leads and participates in investigations, develops plans and executes tasks to solve process problems including Nonconformances (NC), complaint investigations, audit observations and Corrective and Preventive Actions (CAPA). Performs analysis and communicates associated trends.
* Provides day to day support and direction to production such as, but not limited to turning, milling, drilling, EDM, finishing, packaging etc. as required.
* Develops process validation strategy and writes and executes engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation).
* Identifies, leads and implements process improvements for existing manufacturing processes utilizing appropriate engineering principles and standard strategies such as, Lean and Six Sigma principles.
* Performs gage design, measurement system analysis, and gage implementation as required. Is able to use various types of measuring instruments including, micrometers, calipers, comparators, tensile testers, coordinate measurement systems etc. to support engineering testing.
* Develops fixtures and designs tools and has the ability to express and implement ideas with tool designers.
* Leads new equipment acquisition efforts including user requirement specifications, machine selection, installation, validation, employee training, and other related equipment responsibilities as required.
EDUCATION & EXPERIENCE REQUIREMENTS:
* BSc in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree with 4-6 years of experience in manufacturing and/or engineering is required.
* Previous experience working in a regulated industry, such as Medical Device is preferred.
* Six Sigma or Lean Sigma certification or 4 years of experience preferred.
* Experience developing and implementing robust automated manufacturing equipment, preferred.
* Experience with packaging, Laser, and CNC processes and equipment, preferred.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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