Provides technical support of medical device manufacturing activities related to the improvement, development, and troubleshooting of current and new processes including CNC process and programming efficiencies, cost evaluation, quality and capability analysis, production and maintenance.
Provides support to assigned manufacturing areas to meet the requirements for safety standards, quality standards, compliant documentation, production demand, equipment availability and cost.
ENGINEERING TECHNICIAN DUTIES AND RESPONSIBILITIES:
- Provides day to day support and direction to production such as, but not limited to CNC turning, milling, drilling, EDM, as required.
- Participates in engineering projects including planning and completing assigned tasks on-time and with high quality.
- Executes tasks associated with process validation (Installation Qualification, Operation Qualification, Performance Qualification) and engineering studies.
- Assists in process improvements for existing manufacturing processes utilizing appropriate engineering principles and standard strategies as e.g. Lean and Six Sigma principles.
- Assists in measurement system analysis, and gage implementation as required. Is able to use various types of measuring instruments including, micrometers, calipers, comparators, coordinate measurement systems etc. to support engineering testing.
- Assists in developing fixtures and tools.
- Supports tasks related to requisitioning equipment and materials and performing vendor and equipment analysis for engineers to determine cost effective and high-quality processes.
- Checks moderately complex layouts and drawings for clarity, completeness, conformity to standards, procedures, specifications, and accuracy of calculations and dimensions.
- Assists in designed experiments and capability studies, collects and maintains documents, and records on process specifications.
- Is responsible for programming, set-up and debugging of complex equipment or measuring instruments.
- Collects process documentation and prepares training on processes, materials, and equipment.
- Supports and performs preventive maintenance and 5S related tasks.
- Assists in the development of manufacturing and inspection procedures.
- Participates in cross-functional teams which may include, but are not limited to Manufacturing Engineering, Production, Quality Assurance, Finance and Product Development.
- 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).
- Adheres to all company safety policies and procedures and other safety precautions within the work area.
- Acts as a model for the operators in terms of attitude, running machines, following processes and decision making.
- Performs other related duties, as required.
EDUCATION AND EXPERIENCE REQUIREMENTS:
- Associates degree or equivalent work experience/certifications.
PROFESSIONAL EXPERIENCE REQUIREMENTS:
- 2-4 years of experience in manufacturing and/or engineering is required.
- Experience with CNC processes, equipment and related programming software is required.
- Experience with manual machining processes (Mill and Lathe) is preferred
- Previous experience working in a regulated industry, such as Medical Device is preferred.
- Lean Sigma experience preferred.
- Demonstrates strong mathematical competency (Trigonometry and Algebra).
- Demonstrates troubleshooting skills.
- Demonstrates strong written and verbal skills.
- Demonstrates strong computer skills, such as the use of Microsoft Office, CREO, Minitab, and databases, preferred.
- Demonstrates strong organizational skills and is results oriented.
- Demonstrates positive interpersonal skills and professional interactions with coworkers.
- Participates in and understands compliance related activities pertaining to the job assignment including compliance with the Quality System Regulation (QSR), Standard Operating Procedures (SOP), and applicable Work Instructions.
- Follows all laws and policies as they apply to one's job and maintains the highest levels of professionalism, ethics and compliance at all times.
- Supports and operates in a proactive safety environment
- Works in conditions that may be hot, cold, wet and/or noisy along with exposure to fumes, oil, coolants and other manufacturing related chemicals.
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