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Manufacturing/Production Engineer I / Medical Device Industry

Pioneer Data Systems Inc • Monument, CO

Posted 13 days ago

Job Snapshot

Experience - 2 to 4 years
Degree - 4 Year Degree
Pharmaceutical, Medical Equipment, Manufacturing
Manufacturing, Engineering, QA - Quality Control


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Job Description

Position Details:
  • Job Title: Manufacturing/Production Engineer I / Medical Device Industry
  • Duration: 3 months contract, extendable up to 24 months
  • Location: Monument, CO
  • Client has the right-to-hire you as a permanent employee at any time during or after the end of contract.
  • You may participate in the company group medical insurance plan which includes dental and vision.
Job Description:
  • 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. 
  • Provides technical support in identifying continuous improvements to manufacturing operations and implementing new technologies including development of processes, researching current and emerging technologies and evaluating process quality, cost, capacity and capability alternatives. 
  • Supports the needs of manufacturing areas in terms of meeting the requirements for quality standards and compliant documentation, capacity, product availability and cost. 
  • Provides technical support regarding equipment design and development, testing of materials, preparation of specifications and operator instructions, process studies, investigations, root cause analysis, problem solving and report or presentation preparation. 
  • Performs assignments designed to continue the development of professional work knowledge and abilities requiring application of standard engineering techniques, procedures and criteria in carrying out a sequence of related engineering tasks, project management, statistical analysis and presentation of data and technical writing. 
Duties and Responsibilities: 
  • Participates in engineering projects including developing and executing to the plan and schedule and meeting the goals and objectives of the project. Assists in tracking costs, preparing status reports, conducting meetings, and documenting and communicating progress to management. 
  • 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). 
  • Provides day to day support and direction to production such as, but not limited to turning, milling, drilling, EDM, finishing, packaging etc. as required. 
  • Executes engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation). 
  • Identifies and assists in process improvements for existing manufacturing processes utilizing appropriate engineering principles and standard strategies such as, Lean and Six Sigma principles. 
  • Assists in 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. 
  • Assists in developing fixtures and designing tools and has the ability to express and implement ideas with tool designers. 
  • Supports new equipment acquisition efforts including user requirement specifications, machine selection, installation, validation, employee training, and other related equipment responsibilities as required. 
  • 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. 
  • Acts as a liaison to vendors with regard to contracted products, tools & fixtures, and their manufacture. 
  • Performs other related duties, as required.

Job Requirements

Education and Experience Requirements: 
  • Bachelor of Science Degree from accredited institution (or AS degree and actively pursuing BS degree) in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree with 2+ years’ experience
Professional Experience Requirements: 
  • Previous experience in manufacturing and/or engineering is preferred. 
  • Previous experience working in a regulated industry, such as Medical Device is preferred. 
  • Demonstrates strong written, verbal and presentation skills. 
  • Demonstrates strong computer skills, such as the use of Microsoft Office, Minitab, and databases. 
  • Demonstrates strong organizational and project management skills and are results oriented. 
  • Demonstrates positive interpersonal skills and professional interactions with coworkers. 
  • Demonstrates troubleshooting skills. 
Other Requirements: 
  • Must be willing to support global projects including some travel. 
  • Must be willing to support all production shifts. 
  • 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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