Location: Kennesaw,GA, USA
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 Objective:
Provide strategy and leadership for an engineering department to develop new technologies and devices. Improve current devices to improve manufacturing, reliability, and resolve any quality issues. Investigate new technologies for next generation medical devices and identify new business opportunities in collaboration with the business development function. Collaborate with Operations, Quality, Regulatory Affairs, Clinical and Marketing to provide technical support to all Artivion manufactured products.
Responsibilities:
* Provide strategic direction and leadership to rapidly develop new technologies and products
* Improve existing products to enhance manufacturing efficiency and product reliability
* Prioritize and manage US- and German-based R&D projects and teams to establish timelines and goals, ensure projects remain on track & within budget, and lead teams from early-phase prototyping through commercialization
* Direct design and development activities in accordance with established design control system requirements, global regulatory requirements, and testing, development & report writing best practices
* Define minimally viable product goals, actively manage project scope, and work cross-functionally to develop creative pathways to market
* Partner with marketing and clinicians to define product features, select optimal designs, develop value propositions, and ensure ROI & strategic goal alignment
* Collaborate with cross-functional teams including Operations, Quality, Regulatory Affairs, Clinical, and Marketing to offer technical support for commercialized products
* Foster cross-functional collaboration throughout all phases of the development cycle
* Develop and enhance US- and German-based R&D team technical capabilities in alignment with current and future R&D needs
Qualifications:
* Engineering degree in relevant area (biomedical, mechanical, etc.). Advanced degree preferred.
* 10+ years of experience working in medical device research and development (prefer cardiovascular experience).
* 3-5 years of experience leading and mentoring diverse engineering teams. Managing international teams strongly preferred.
* Demonstrated track record with all aspects of medical device development (from concept through commercialization) including design control, scope management, & aligning R&D outputs to meet global regulatory requirements
* Project management experience including scheduling, budgeting, and resource allocations.
* Demonstrated skill and proficiency generating oral and written communications to align internal cross-functional teams and external stakeholders
* Strong interpersonal skills and team leadership capabilities, including development of direct reports.
* Knowledge of advanced cardiac and vascular medical devices and technologies such as stents, heart valves, and vascular grafts.
* Knowledge of medical device delivery systems (preferred endovascular experience)
* Experience developing test methods and performing design verification and design validation testing.
* Familiarity with common medical device manufacturing processes such as injection molding, extrusion, component bonding, device assembly, etc.
* Domestic and International travel (as required)