Sr. Principal R&D Engineer

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:

Leverage extensive knowledge and experience of material science and engineering design to advance the development of advanced medical devices in the endovascular or catheter-based implantable class III medical device space. Identify and develop new programs and next generation and disruptive technologies and assess through partnerships and collaboration with clinicians and external and internal partners.

Lead planning, coordination, and execution of design control activities throughout all phases of product development including drafting and updating design and development plans, design verification and validation non-clinical test plans, conducting design reviews, creating formal documentation such as test protocols and reports, and design description document. Coordinate with R&D as well as cross-functional teams to ensure alignment in product development activities. Characterize and qualify concepts, products, and methods.

Lead and guide project team members, and foster and mentor the advancement of junior engineers throughout the stages of new product development

Responsibilities:

• Successful commercialization of R&D new product development efforts with deep technical knowledge preferably in cardiovascular field
• Lead planning, coordination, and execution of design control activities including development of design inputs/outputs, design and development plans, design verification and validation plans.
• Project management experience including timeline and budget management, presenting to executive management, minimizing project risk, and documentation creation and organization.
• Serve as technical project lead for projects and work with cross-functional team throughout all phases of product development, provide technical leadership and support for product sustaining post regulatory approval/commercialization.
• Lead non-clinical testing activities including developing test plans, test protocols, and reports. Coordinate with internal and external test facilities and ensure timely execution of tests. Analyze and present results, applying statistical analysis, as necessary.
• Support technical update meetings, design control review meetings, completion of required project deliverables, and execute follow up activities with cross functional team members on action items.
• Investigate and evaluate technologies for future generation of medical devices through applying sound engineering principles and practices. This includes:
• Design, fabrication, and testing of prototypes.
• Consulting with physician users to optimize and select between potential designs,
• Present recommendations to senior management
• Develop intellectual property IP.
• Generate engineering models, drawings, prototypes, and work instructions. Evaluate and make recommendations on concepts and design modifications based on key stakeholder feedback Establish/characterize product and/or process specifications.
• Collaborate with physicians and other key stakeholders to define user needs and design requirements
• Delineate solutions to difficult technical hurdles faced in new product development.
• Work with outside OEM Suppliers, internal/external machine shops and or other departments/groups.
• Design and implement custom equipment/ tools, fixtures and/or off the shelf equipment/ tools, fixtures for highly capable manufacturing processes for new and existing products through frequent interaction with R&D, Manufacturing Engineering, Quality Engineering, and Operations

Qualifications:

• BS Degree in Mechanical Engineering or Biomedical Engineering; MS or PhD in an Engineering, Math, or Science discipline also preferred or comparable education
• Minimum 12+ (15 preferred) years of relevant work experience or a combination of education and work experience (e.g. 10+ years with MS or 7+ years with PhD)
• Extensive experience with design, development, and non-clinical testing of Class III cardiovascular implantable devices in a heavily regulated environment (FDA IDE/PMA, EU MDR, etc.), preferably with endovascular stent grafts and delivery catheter systems (knowledge of Japanese (PMDA) and Chinese (CFDA) device testing standards desired)
• Ability to work onsite/hybrid. Remote work which includes up to 50% of travel may be considered based on overall candidate qualifications
• Exemplary verbal, technical, written, and communication skills
• Extensive experience in independent preparation of technical, design control, and regulatory submission documents in an international context.
• Deep knowledge and experience with fatigue and durability in class III medical devices including finite element analysis (FEA) and in vitro durability testing
• Knowledge in materials associated with medical devices such as polymers, metals (e.g nitinol and stent processing), textiles, sutures, etc.
• Experience developing in vitro, in situ, in vivo, and ex vivo mechanical, thermal, and/or biomechanical tests and experiments with cardiovascular medical devices
• Experience creating 3D CAD models and 2D engineering drawings; must be a proficient user of SolidWorks; must be familiar with ASME Yl4.5-2009
• Statistical data analysis, Minitab knowledge preferred
• Experience developing, authoring, or improving Quality System procedures and practices is preferred
• Knowledge of common medical device standards such as ISO 62366, ISO 10993, ANSI HE75, ISO 11607, IEC 60601, ISO 15223, etc
• Experience with design and process qualification
• Knowledge in processes associated with medical device manufacturing such as shrinking (reflow), RF welding, laser/thermal/adhesive/solvent bonding, welding & cutting, braiding, coil winding, insert molding, hydrophilic coating, injection molding, extrusion, pad printing, laser marking, tray sealing, manual assembly, automated assembly, etc.
• Knowledge and experience with New Product Development and Design Controls
• Knowledge and experience of mechanical testing, biomaterials, devices, and tissue biomechanical testing and developing and procuring conceptual and functional prototypes
• Experience performing and documenting FMEAs and risk management activities

Qualifications (Desired)

• Experience developing in vitro, in situ, in vivo, and ex vivo mechanical, thermal, and/or biomechanical tests and experiments with cardiovascular medical devices
• Experience creating 3D CAD models and 2D engineering drawings; must be a proficient user of SolidWorks; must be familiar with ASME Yl4.5-2009
• Statistical data analysis, Minitab knowledge preferred
• Experience developing, authoring, or improving Quality System procedures and practices is preferred
• Knowledge of common medical device standards such as ISO 62366, ISO 10993, ANSI HE75, ISO 11607, IEC 60601, ISO 15223, etc
• Experience with design and process qualification
• Ability to work well in a team
• Ideal candidates live around the Atlanta metro area (or willing to relocate) and comfortable commuting to Kennesaw HQ 2-3 days per week.