Manufacturing Engineer II (Medical Devices Industry, Denver, CO)
Description of Duties:
 Plan, design, setup, modify, optimize and monitor manufacturing processes and ancillary
processes in order to produce high quality product in the most cost effective manner.
 Design manufacturing systems and processes for the introduction of new products or for the
improvement of existing products, including documentation.
 Develop, plan and execute Process Qualification.
 Apply Lean principles and Six Sigma problem solving techniques to manufacturing and
ancillary processes.
 Knowledgeable about Design for Manufacturability, Assembly and Test, and clearly analyze
and communicate manufacturability, cost and quality tradeoffs.
 Work with design engineers to ensure all product and system requirements are taken into
account from the initial product conception to finished result.
 Identify or conceptualize, purchase and qualify new equipment, tools and fixtures for
manufacturing.
 Develop and monitor preventative maintenance plans for manufacturing equipment or tools.
 Perform Root Cause Analysis and Corrective Action related to non-conforming material and
customer complaint investigations and response.
 Research, test and implement alternative materials, processes or suppliers.
 Knowledgeable about and comply with regulatory requirements in the medical device
industry.
 Manage budget aspects of projects.
Qualifications:
 B.S. in an Engineering Discipline or equivalent, required.
 Mechanical Engineering, Electrical Engineering, Software or Manufacturing/Industrial
Engineering preferred, Masters Degree preferred.
 3-10 years minimum experience in a manufacturing environment.
 Experience with manufacturing processes associated with electro-mechanical devices, such as
interconnection, fastening of metal and plastic parts and electronic assembly.
 Knowledge of component manufacturing processes including sheet metal forming, machining
and injection molding.
 Experience conceptualizing or designing and assessing Manufacturing Fixtures, including Logic
Controllers.
 Experience implementing Lean and Visual manufacturing processes.
 Knowledge of defining, collecting, analyzing and presenting data that is relevant and
actionable
 Experience implementing software data collection and test systems in Manufacturing,
preferred.
 Knowledge of Mechanical, Electrical and Manufacturing Standards required.
 Knowledge of Software and FDA Medical Device standards, preferred. (ASME Y14.5, IEC 601,
IPC, GMP, ISO, FDA QSR).
 Proficient in MS Office (Word, Excel, PowerPoint, Access).
 Knowledge of CAD software (Pro-E, Autocad or Solidworks) preferred.
 Knowledge of MRP, ERP production, document control, and statistical analysis software.
 Ability to read, analyze, and interpret common scientific, technical journals, general business
periodicals, professional journals, technical procedures, and governmental regulations.
 Ability to write reports, business correspondence, and procedure manuals.
 Ability to effectively present information and respond to questions in Team Meetings and
Technical Reviews.
 Ability to interface with people of different origins, cultures and orientations.
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