Engineer III - Design Quality Assurance

Engineer III - Design Quality 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 III – Quality Design Assurance will be an engaged core project team member supporting the design and development of complex medical device products.  The Engineer III – Quality Design Assurance represents the Quality Assurance function on multiple design and development projects, which can include catheters, guidewires, electrophysiology, and other related technologies. The Engineer III will act with a high degree of autonomy, collaboration, and attention to detail to assure adherence to product development and design controls processes. 

What you'll get to do everyday: 

• 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.
• Support test method development and test method validation.
• Initiate, review, and approve disposition for nonconforming product and investigate/analyze in-house nonconformances for finished devices and monitor quality trends.
• Review Change Orders, Deviation Authorizations, Verification/Validation Protocols, Final Qualification Protocol Reports, as well as Inspection Procedures.
• Lead efforts to continuously improve quality management systems and 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, dFMEA and supporting pFMEA creation.
• Provide input for quality management review, investigate/analyze customer complaints and support Regulatory Affairs to monitor customer complain trends, as needed.
• Facilitate customer audits and assist as needed with external audits such as FDA and ISO.
• Maintain a positive demeanor while interacting with personnel from all areas of Medevio to foster improved quality and reduced cost.
• Promote a quality culture by clearly communicating the importance of adherence to procedure, providing rationale and context behind decisions, and seeking out areas for continuous improvement.
• May mentor and provide guidance to Quality Assurance Technicians.
• Ensure documentation accuracy and completeness of product and process development activities.
• Other duties assigned as required.

What we're looking for: 

• Bachelor’s degree in Engineering or related field required.
• Minimum 5 years of experience in related engineering work.
• Experience in the medical device industry as a Quality Assurance Engineer strongly preferred.
• Design Controls experience preferred.
• Experience with the use and application of gages, inspection tools, and test equipment.
• Practical experience/familiarity with some or all of the following: ISO 13485, FDA Quality System Regulations, Design Controls, Good Manufacturing Practices, Good Laboratory Practices, ISO 14971, MDR, sterilization processes, cleanrooms, and other applicable standards.
• Must be able to read and understand component/product specifications.
• Ability to develop practical technical knowledge related to products that the position will support (guidewires, catheters, leads, electromechanical devices, or related technologies).
• Possess a customer-focused mindset and ability to work collaboratively across functional groups.
• Must be highly organized and can manage multiple projects concurrently.
• 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.

Medevio is committed to providing competitive total compensation and benefits packages. The expected hiring range for this position is between $100,000 and $117,00 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 on company and indidvidual performance. Our total compensation package 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.