Essential functions include, but are not limited to:

• Provide Design Quality (Design Assurance) Engineering project leadership to ensure the successful development and commercial launch of new products. Serve as a Quality Core Team member on NPD projects.
• Develop design control tools for global application of harmonized design control processes.
• Provide Quality Engineering project leadership to ensure proper application of design controls, risk management, and the investigation/correction of design failures/challenges.
• Create Validation Master Plans and Validation Project Plans to ensure that all validation tasks required supporting corporate projects are identified and completed within established time frames.
• Establish, review, and approve design input requirements as appropriate.
• Perform, review, and approve the translation of input requirements into design output documents.
• Develop, conduct, review, and approve design verification / validation protocols and reports that demonstrate the design output fulfills the design input requirements.
• Provide Quality Engineering technical leadership in resolving quality issues.
• Develop, review and approve risk management documents, including plans, reports, and FMEAs.
• Develop, review and approve documents required for the Design History File.
• Develop, conduct, and document qualifications/validations to ensure products processed are proven to be reliable, safe, and effective prior to release.
• Serve as a Subject Matter Expert during Internal, Supplier Quality System, and External audits, as assigned.
• Provide post-launch product support, as necessary.
• Conduct investigations, bounding, documentation, review and approval of non-conformances and CAPAs as necessary.
• Interface with multiple manufacturing facilities (specifically Hechingen, Germany) as required.
• Effectively complete “other” functions that may be assigned.

Qualifications:

• Minimum of a Bachelor’s degree in an Engineering field or equivalent experience.
• Minimum of 5+ years hands-on experience; preferably in an 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.
• Experience with cardiovascular implantable medical devices preferred.
• Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, DFMEA)
• Knowledge of cardiac anatomy, physiology, and primary disease states preferred.
• Proven experience in design controls and risk management, from design concept to commercialization.
• Good knowledge of application of statistical methods and acceptance sampling within a regulated industry such as medical device manufacturing or pharmaceutical.
• Specific experience designing, preparing, executing, and statistically analyzing validations, as well as developing report packages, to approve equipment, processes, and software used in the receipt, testing, processing, storing, and distribution of raw materials, components, and tissues/products.
• Ability to understand Artivion Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency. Ability to interface with regulatory bodies to present technical information.
• ASQ, CQE, CQA Certification preferred, but not required.

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