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Engineer III - Product Engineering

Date: Jul 10, 2021

Location: Fridley – Minnesota, US, 55421

Company: Heraeus

[title]
Engineer III - Product Engineering
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.

 
 

This position involves the design and development of medical products from concept through design validation. This individual will have engineering responsibilities for the development of new finished medical products and will be instrumental in guiding the development of the key prototype processes for Design for Manufacturability concepts.

 

Your Role and Responsibilities:

  • Lead or contribute to design, development, validation activities through product life cycle for neuromodulation and interventional device products in accordance to project scope
  • Execute deliverables for Design Control process to deliver the desired product to production in a cost-effective manner while hitting product performance and profitability goals. Support product in production until product meets intended profitability and quality targets.
  • Complete deliverables to Design History File(s), Design Control, Design Validation, and all necessary activities in accordance to all internal and external processes, procedures, and standards (MDR, ISO, EN, etc.).
  • Read and understand customer specifications/requirements to translate into clear, concise performance and functional requirements.
  • Make data driven decisions utilizing statistical tools such as DOE, tolerance stack-up analysis, and Minitab
  • Assess, anticipate, and mitigate risks through risk assessment tools such as FMEA, root cause analysis, etc. throughout the product development lifecycle.
  • Work with development technicians/operators to perform hands on prototyping and testing. Provide directions and instructions to development/production operators and technicians on new and revised processes.
  • Coordinate new equipment/tooling/fixturing identification, procurement, and verification. Participate in execution of these activities as needed.
  • Demonstrate and utilize tried and true engineering methods and resources to streamline the development process.  Evaluate new technologies and ideas for new products.
  • Use statistical tools to analyze data, make development decisions, and improve process capability (Six Sigma, SPC, DOE)

 

What is Required for this Role:

  • Bachelor’s Degree in Engineering or related technical field required
  • A minimum of 5 years of relevant medical device work experience including complex assemblies required (lead design, neuromodulation experience, and project/people management are a plus)
  • Knowledge of clinical applications for interventional medical procedures helpful
  • Proven experience in 3D modeling (SOLIDWORKS preferred) and working knowledge of drafting specifications such as GD&T
  • Experience in a regulated environment and demonstrated competence in required documentation and industry accepted practices such as Good Manufacturing Practices (GMP), ISO 13485 Design Control, and Quality Systems Regulation (QSR)
  • Knowledge and effective application of engineering tools (Risk Analysis, FMEA, DOE, Process Validation, protocol/report documentation, SPC) required
  • Familiarity with process instrumentation and controls, development, and characterization of test methods for selection, verification and validation of components, sub-systems and assemblies.
  • Excellent technical writing skills


Nearest Major Market: Minneapolis