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Engineer II - Quality Design Assurance

Saint Paul, Minnesota

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Job ID 57951 Functional area Quality Assurance Full-time/part-time Full Time Experience level Professional

Engineer II - Quality Design Assurance

[title]
Engineer II - Quality Design Assurance
Fridley

About Heraeus

Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family-owned global technology group we help our customers to always being one step ahead.


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.

Position Summary

The Engineer II – Quality Design Assurance will be an engaged core project team member supporting the design and development of complex medical device products.  The Engineer II – Quality Desing Assurance represents the Quality Assurance function on multiple design and development projects, which can include catheters, guidewires, electrophysiology, and other related technologies. The Engineer II will work with a high degree of collaboration to ensure adherence to quality procedures and standards.  

What you'll get to do every day:

  • Actively participate in complex medical device design and development projects, collaborating across functional areas to support and drive project deliverables to completion.  
  • Design and/or specify inspection and testing plans/procedures/systems to ensure products conform to specifications and quality standards. 
  • Propose and implement possible solutions/improvements, utilize the Corrective and Preventive Action (CAPA) system. 
  • Investigate/analyze in-house nonconformances for finished devices and monitor quality trends. 
  • Initiate, review, and approve disposition for Nonconforming Product.
  • Review Change Orders, Deviation Authorizations, Verification/Validation Protocols, Final Qualification Protocol Reports, as well as Inspection Procedures. 
  • Lead efforts to continuously improve product quality, while ensuring safety, efficacy and regulatory compliance. 
  • Support all functional departments to ensure compliance with Quality System and lead continuous improvement efforts of the Quality System. 
  • Represent Quality Assurance on product development teams, including developing Quality Plans and Risk Management Plans. 
  • Facilitate customer audits and assist as needed with external audits such as FDA and ISO. 
  • Interface with personnel from all areas of HMC to foster improved quality and reduced cost. 
  • Provide input for quality management reviews.
  • May mentor and provide guidance to Quality Assurance Technicians. 
  • May Investigate/analyze customer complaints and support Regulatory Affairs to monitor customer complaint trends and maintain compliance to complaint system.
  • Ensure documentation accuracy and completeness of product and process development activities.
  • Develop and monitor quarterly goals. 
  • Provide periodic more formal updates on progress of projects. 
  • Participate in company meetings and training sessions. 
  • Other duties may be assigned as required.

What we're looking for:

  • Bachelor's Degree in Engineering (or related field), required. 
  • Minimum 2 years of related engineering work experience.   
  • Experience in the medical device industry as a Quality Assurance Engineer, strongly preferred. 
  • Experience with the use and application of gages, inspection tools, and test equipment. 
  • Practical experience/familiarity with ISO 13485, FDA Quality System Regulations, Design Controls, Good Manufacturing Practices, Good Laboratory Practices, ISO 14971, sterilization processes, cleanrooms, and other applicable standards. 
  • Possess a customer-focused mindset and ability to work collaboratively across functional groups. 
  • Must be highly organized and can manage multiple projects concurrently. 
  • Ideally possess practical knowledge related to products that the position will support (guidewires, catheters, leads, electromechanical devices, or related technologies).  
  • Must possess good written and verbal communication skills as well as team building skills, basic PC skills, and have working knowledge of Microsoft Word, Excel, and Minitab. 
  • Must be able to read and understand component/product specifications.

Medevio is committed to providing competitive total compensation and benefits packages. The expected base salary hiring range for this position is between $85,000 to $107,000 annually, based upon a full-time schedule. This is a good faith estimate on the applicable range. Base salaries are determined by taking a variety of factors in account, including, but not limited to, candidate qualifications, geographic locations, market conditions and internal equity. This position is bonus eligible, with a target bonus of 10% of base salary depending upon company and individual performance. Our total compensation package also includes eligibility for comprehensive medical, dental, and vision coverage, a 401(k) plan with company match, education reimbursement, paid parental leave and paid time off.

Curious? Apply now!

Heraeus is proud to be an Equal Opportunity Employer. We provide fair and equal consideration to all qualified applicants, regardless of sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other legally protected characteristic. Diversity is at the heart of our Vision, Mission, and Values. We are dedicated to cultivating an inclusive workforce that reflects a broad spectrum of cultures, backgrounds, and perspectives.

Any further questions?

If you need any assistance or have questions, please contact hrdirect-americas@heraeus.com or visit our website at jobs.heraeus.com.


ReqID: 57951
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