Engineer II - Process Development

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Date: Nov 25, 2023

Location: Fridley – Minnesota, US, 55421

Company: Heraeus

Engineer II - Process Development

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.

This position is responsible for providing expertise in centerless wire grinding, developing manufacturing processes for guidewires, balloon catheters, leads, and similar products. The incumbent should demonstrate competence in medical device development and pilot production/manufacturing environment. This includes supporting and owning processes from development through transfer into production, including capability and quality/documentation deliverables, as well as process cost and technology improvements. The incumbent will also understand process characterization tools and utilize them as needed across various technologies.

The following challenges await you:

Contribute to process development, design, validation activities through product life cycle for medical device products in accordance with project scope
Utilizes process characterization skills and tools such as Design of Experiments (DOE), pFMEA, scale up factors, mitigation of risks, and capability analysis.
Ensure that proper manufacturing technology and processes are selected, developed, implemented, maintained, qualified, and documented to successfully introduce new products into manufacturing.
Assume responsibility for completeness and accuracy of developed processes, complete documentation (BOMs, routings, and manufacturing/inspection processes), operator and technician training, process capability, process quality and controls, and process costs.
Coordinate new tooling/fixturing identification, design, procurement, and validation.
Assist in part review at quote or PO stage based on project need and process knowledge.
Communicate with customers and represent Heraeus Medevio professionally.

Your profile:

Bachelor’s Degree in Engineering or related technical field strongly preferred; other relevant postsecondary education, training and experience may be considered in lieu of a Bachelor’s Degree.

A minimum of 2 years of relevant work experience required; 1 year of relevant work experience may be substituted for a graduate degree.
Familiarity with cGMP/GLP/GDP guidelines, ISO 13485, 21 CFR part 820, etc.
Experience with catheter, balloon catheter, leads, or guidewire manufacturing processes preferred (Centerless wire grinding, laser 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.
Must possess proficient written and oral communication skills and ability to utilize MS Office suite tools.
Previous experience in document control and ERP systems, SAP preferred
Ability and willingness to travel internationally to support process, product, and equipment transfers is highly preferred (5% - 15% travel).

Nearest Major Market: Minneapolis

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