Engineer III - Product Engineering

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Date: Jun 21, 2024

Location: Fridley – Minnesota, US, 55421

Company: Heraeus

[title]
Engineer III - Product Engineering
Location Fridley – Minnesota
Permanent 
Full Time
 

 

About Heraeus

Solutions from the Heraeus Group provide faster internet, rid water of germs, and keep hearts beating in time. As a broadly diversified and globally leading family-owned technology company, we combine materials expertise and cutting-edge technologies to create products used all over the world with one thing in common: World-class quality.


About Heraeus Medevio

Together we improve lives. At Heraeus Medevio, we bring lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by Heraeus Group, we are committed to the growth of our teams and organization by providing an open space for open minds.

To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today.

 

The primary responsibility of this position is to act as an Engineer Ill -Product Engineering of the Production department for Heraeus. The Engineer Ill -Product Engineering is responsible for the day-today execution of all Production processes to meet customer demands while maintaining cost effectiveness and quality expectations. Furthermore, they are fully responsible for issues related to the Production operations department.

 

Your Role and Responsibilities:

  • Conduct, design, and develop process activities throughout the product lifecycle.
  • Complete activities for concept generation and use good technical problem-solving based on customer interests, budgets, and market research.
  • Conduct engineering analysis on designs, concepts and associated research.
  • Create/facilitate documentation for requirements, design output, design verification, testing using Heraeus and/or customer's QMS.
  • Coordinate and execute effective cross-functional collaboration to move forward in the product development cycle.
  • Communicate complex information concisely and clearly when working with customers, team members, and others. Identify solutions and form resolution implementation with others, according to project milestones.
  • Facilitate and make technical decisions on projects (i.e. vendor selection, decisions critical to quality on design, concept selection, etc.).
  • Develop test methods for balloon catheters.
  • Work directly on design history files for submission to regulatory agencies required.
  • Design and test delivery catheter shapes that reach desired anatomical site during cardiac procedures.

What is Required for this Role:

  • Bachelor's degree in Mechanical Engineering and five (5) years as a Mechanical Engineer in the medical device industry or a Master's degree in Mechanical Engineering and two (2) years as a Mechanical Engineer in the medical device industry.
  • Solid works to design class II or class Ill medical devices.
  • Translating user requirements to product requirements.
  • ISO-13485 and EU-MDR requirements.
  • Test method validation for attribute, variable and analytical tests using Minitab for medical devices.
  • IQ, OQ, and PQ validation protocols for laboratory equipment.
  • Working on design history files for submission to regulatory agencies.
  • Risk management documentation including FMEAs and hazard analysis.
  • Travel Required: Up to 10% domestic and international.


Nearest Major Market: Minneapolis

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