Design Quality Engineer II

Company Overview

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. Artivion’s four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com.

Position Responsibilities:

• Provide Design Quality Engineering support for NPD. Serve on the Technical Teams for Aortic programs in design control.  Support regional expansion; specifically bringing CE Marked implantable products into the US.
• Provide Quality Engineering technical support in resolving quality issues.
• Create, review and approve documents required for the Design History File.
• Provide support to R&D to ensure design verification testing is clinically relevant and test samples represent clinical/commercial builds.
• Develop, conduct, and document qualifications/validations to ensure that designed and manufactured products are proven to be reliable, safe, and effective prior to release.
• Design, prepare, execute, and analyze validations to approve equipment, processes, and software used in the testing, processing, storing, and distribution of products.
• Develop, prepare, and execute test methods and test method validations. Analyze results of method validation to prove methods are reliable, repeatable, and effective for product release.
• Develop and apply statistical methods to verification, validation/qualification, and product inspection plans and ensure statistical evaluation is predictive of real-world results.
• Collect, statistically analyze, and develop report packages to support verification, validation, and engineering studies.
• Assess equipment changes for process validation or design verification needs.
• Work with project teams to develop the Risk Management File for new product development. Ensure periodic reviews where applicable.
• Work with project teams and necessary departments to identify appropriate process and product hazards, probabilities, severities, and mitigations for Risk Analyses.
• Support Internal, External, and/or Supplier Quality System Audits, as assigned.
• Monitor post product data (e.g., Complaints, Corrective and Preventive Actions (CAPA), Non-conformance Reports (NCRs), Customer Feedback information, etc.) for impact to the Risk Management Files.
• Support post market surveillance reporting through analysis of feedback data
• Be knowledgeable on all the applicable standards, regulations, and procedures related to medical devices, both internal and external, as required.
• Design QE duties include:
• Partner with R&D and other cross functional groups to support successful development and commercial launch of new products.
• Partner with R&D and other cross functional groups to support the proper application of design controls, process validation, risk management, and the investigation/correction of design failures/challenges.
• Review and approve design input requirements as appropriate.
• Review and approve the translation of design input requirements into design output documents.
• Establish and/or maintain Risk Management Files to support product lines and corporate projects.
• Review and approve design verification / validation protocols and reports that demonstrate the design output fulfills the design input requirements.
• Review, approve, and validate Test Methods.
• Conduct investigations, documentation, review, and approval of non-conformances, CAPA’s and customer complaints as necessary.

Qualifications:

• Minimum of a Bachelor’s Degree in an Engineering or science field, or equivalent work experience.
• Minimum of 3 years hands-on experience; preferably in a FDA regulatory industry (i.e., pharmaceutical, biomedical, medical device field) with an in-depth knowledge of current Good Manufacturing Practices, Quality System Regulations, and ISO Standards.
• Specific experience in medical device Design Controls for developing and preparing design specifications and effectively demonstrating that the design output fulfills the design input.
• Specific experience designing, preparing, executing, and statistically analyzing validations, as well as developing report packages, to approve equipment, processes, methods and software.
• Specific experience in the application of statistical methods and acceptance sampling within a regulated industry such as medical device manufacturing or pharmaceutical.
• Personal computer skills, i.e., word processing, spreadsheets, data analysis.
• Risk Management Experience preferred, not required.
• ASQ, CQE and CQA certifications preferred, not required.

This is a remote position. International travel up to 20%.