Biomerics FMI, LLC
Biomerics is a world class contract manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in the design, development, and production of medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for the vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.Please explore our website for more information about our offerings and capabilities.
Manufacturing Engineer
Biomerics FMI, LLC
Biomerics FMI, LLC
1605 Enterprise
75751 Athens , TX
Job Description: 

Manufacutring Engineers are responsible for supporting and improving existing processes. The Manufacturing Engineer will assist other enigneers in the execution of projects and protocols. The Manufacturing Engineer will participate in problem solving teams and is responsible for the process design, operation and implementation. The candidate will be able to improve industrial processes in order to maintain efficiency, reduce cost, improve sustainability and maximize profitability.

Responsibilities Include: 
  • Ability to plan the practices of manufacturing; to research and to develop tools, processes, machines and equipment; and to integrate the facilities and systems for producing quality products with the optimum expenditure of capital
  • Design, run, test and upgrade systems and processes
  • Develop best practices, routines and innovate solutions to improve production rates and quality of output
  • Provide process documentation and operating instructions
  • Perform risk assessments
  • Execute qualification protocols (IQ, OQ, PQ, PPQ)
  • Use Computer-Aided Design software
  • Understand and interpret data
  • Support quality and process improvement
  • Ability to test parts and products in accordance with instructions
  • Support processes improvement
  • Proficient CAD or AutoCAD skills
  • Knowledge of process related standards, preferably within the Medical Device industry
  • Investigate and document quality issues
  • Should be capable of performing Gage R&Rs / Measurement System Analysis (MSA)
  • Assess project requirements
  • Measure performance of mechanical and labor functions
  • Must possess a 4-year Bachelor's degree in Engineering, Mechanical or Industrial preferred
  • 2 years of experience in Medical Device manufacturing operations preferred
  • Knowledge of and understand ISO, QSR/GMP and FDA requirements  
  • Proficient in AutoCAD, SolidWorks, Minitab, Word, Excel and Project
  • Experience with design, review, execution, and approval of Installation, Operation and Process Qualification protocols and reports (IQ/OQ/PQ)
  • The ability to interact with all levels of the organization
Special Skills/Abilities/Knowledge: 
  • Process development
  • Risk assessment
  • Data analysis
  • Working knowledge of ISO and FDA regulation within the Medical Device Industry
  • Experience with Six Sigma and Lean preferred
  • Must be a self-starter with good time management skills and practices
  • Must possess good mechanical aptitude
  • Must possess excellent communication and interpersonal skills
  • Must be able to communicate professionally with vendors
  • Must demonstrate good team skills
  • Bilingual fluency, Spanish/English is a plus