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Engineer III - Process Development

Date: Apr 28, 2021

Location: Fridley – Minnesota, US, 55421

Company: Heraeus

[title]
Engineer III - Process Development
Location Fridley – Minnesota
Permanent  
Full Time
 

Imagine a job where you will have the opportunity to do exciting and challenging work, while collaborating with extraordinary colleagues. A company that invests in you and your career, providing the training, mentoring, development and support you need to be successful now and in the future. If you want a career without limits with a market-leading family-owned, global company where you can make an impact, then imagine an opportunity at Heraeus. Every day, our worldwide team of approximately 14,900 employees are bringing forward new ideas and solutions that are impacting and transforming everything from healthcare to renewable energy to e-mobility to high-tech and telecommunications.

 
 

Hands-on engineer responsible for providing expertise in developing manufacturing processes for guidewires, catheters, and similar products. Demonstrates competence in medical device and manufacturing environment. Own process from development through production including process development, capability, and quality deliverables, as well as process cost and technology improvements. Understands process characterization tools and uses them as needed across various technologies.

 

Your Role and Responsibilities:

  • Lead or contribute to process design, development, validation activities through product life cycle for interventional device products in accordance to project scope
  • Assess and provide input for product design for manufacturing.
  • Develops processes, fixtures, and equipment for project requirements.
  • Utilizes process characterization skills and tools such as Design of Experiments (DOE), pFMEA, scale up factors, mitigation to foreseen risks, and capability analysis. This knowledge may be leveraged across various technologies as needed.
  • Ensure that proper technology processes are developed, implemented, maintained, and documented to successfully introduce new products into manufacturing.
  • Involved in prototyping, process development, confirmation runs, and validation. Available to support and trouble shoot production issues as needed.
  • Assume responsibility for completeness and accuracy of developed processes (i.e., lead, manage, communicate, complete documentation, train) including ownership of process capability, process quality and controls, and process costs.
  • Work with development and production operators and technicians on new and revised processes.
  • Assist in and lead new equipment identification, procurement, installation qualification, document creation, and training. May participate in execution of these activities as needed.
  • Coordinate new tooling/fixturing identification, procurement, and verification. Will participate in execution of these activities as needed.
  • Identify new technologies in accordance with site and customer priorities to improve efficiency, quality, reduce costs, and meet market technology needs.
  • Responsible for part review at quote or PO stage based on project need and process knowledge.
  • Support business line and project engineering with accurate communication and representation of HMC’s capabilities.

 

What is required for this role:

  • Bachelor’s Degree in Engineering (Mechanical, Biomedical) or related technical field required.
  • A minimum of 5 years engineering experience within medical device development or manufacturing environment
  • Familiarity with cGMP/GLP/GDP guidelines, ISO 13485, 21 CFR part 820, etc.
  • Demonstrated strong technical writing skills to own and drive process and qualification documentation required
  • Experience with guidewires or catheter manufacturing processes preferred (Wire grinding, profiler, inspection equipment, and CNC machining are desired)
  • Demonstrated experience of process development, capability, optimization, and validation. Application of statistical and analytical methods such as DOE highly desired.
  • Experience with troubleshooting, maintenance and repair of manufacturing equipment.
  • CAD/CAM experience or training; SolidWorks highly desired or equivalent job experience.
  • Must possess proficient written and oral communication skills and ability to utilize MS Office suite tools
  • Previous experience in document control and SAP preferred
  • Ability and willingness to travel internationally to support process, product, and equipment transfers is highly preferred (5% - 15% travel)
  • Proficiency in reading, writing and speaking English. Must be able to clearly articulate and listen attentively to questions, concerns and feedback from coworkers and customers.  Must be able to create legible, accurate, and detailed documents that clearly communicate product and manufacturing expectations
  • Highly motivated hands-on engineer with the ability to work independently and as part of a cross-functional team


Nearest Major Market: Minneapolis