Biomerics
  • Salt Lake City, UT, USA
  • doe
  • Full Time

Company Description: 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.

 

Job Description:

The candidate will be responsible for managing the execution of projects, regardless of scale. The candidate will work within the constraints of budget, schedule, and scope while managing risk and ensuring adherence to established processes and methodologies. The candidate will also be responsible for Design for Moldability assessment, new tool procurement, de-bugging, process development, tool validation, and work instructions.  The engineer will also support other engineers on projects as an injection molding and process development subject matter expert. As this is a hands-on position, the candidate will spend 50-60% of their time on the floor or at the tool bench. The candidate will report to the Molding Technology Manager.

 

Roles and Responsibilities Include:

  • Interacting with customers, suppliers, and internal resources.
  • Demonstrating advanced knowledge of project and program management principals.
  • Using project management tools to manage large and complex projects or programs.
  • Mentoring other project managers.
  • Defining and managing scope, time, and resources of large scale, complex projects or programs.
  • Facilitating identification of project or program risks, developing and assigning responsibility for mitigation actions, and managing the mitigation plan.
  • Refining project management methodologies for quality and project or program risk management.
  • Synthesizing critical information and communicating business implications to stakeholders.
  • Identifying, justifying, and implementing improvements and new technologies.
  • Providing DFM (Design for Manufacturability/Moldability) to both external customers and internal project teams.
  • Managing the mold procurement process from order through mold design, build, sampling, and validation.
  • De-bugging injection molding tools.
  • Developing injection molding processes using scientific/de-coupled injection molding principles.
  • Validating injection molding tools.
  • Developing injection molding work instructions.

 

 

Requirements: 

  • A minimum of 5 years of related work experience in the medical device field (Required).
  • Bachelor's degree in an engineering or related field (Plastics, mechanical, manufacturing, or materials preferred).
  • The ability to lead a team toward operational objectives with aptitude to contribute to strategic goal-setting for department (Required).
  • Strong customer/supplier/vendor communication skills.
  • RJG Master Molder I cerrtification (Preferred).
  • A Six Sigma Green/Black Belt or ASQ CQE certification (Preferred).
  • The ability to perform statistical analysis (DOE, capability, GR&R, etc.) using Minitab software along with root cause analysis (Required).
  • Experience and understanding of de-coupled injection molding and structured process development (Required).
  • Hands-on experience setting and running injection molds
  • Beginning / Intermediate experience level in SolidWorks
  • Mold fill simulation and analysis experience (Preferred)
  • Must be proficient in Microsoft Office (e.g. Word, Excel, PowerPoint, etc.) (Required).
  • Must be able to lift 50 lbs. un-assisted (Required).
  • Must be able to work in a fast paced environment with little to no supervision.
  • Must have experience with medical process validation, including:
    • Must be capable of supporting validation definition and execution (IQ, OQ, PQ), test method definition, root cause analysis, gage R&R, and measurement systems analysis (MSA) (Required).
    • Experience and understanding of plastic injection mold fabrication processes (Preferred).
    • Experience and understanding of the development and design of plastic parts, insert molded parts, and assemblies (Preferred).
    • The ability to conduct design review(s) of hot/cold runner injection molds (Preferred).

 

 

Biomerics
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