AtriCure, Inc. provides innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator® Synergy™ Ablation System is the first and only medical device to receive FDA approval for the treatment of long standing persistent Afib and we have treated over 200,000 patients over the past ten years. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, with more than 130,000 implanted to date. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
The Senior Materials Engineer at AtriCure will act as a subject matter expert and/or work in a project and process support role for our Engineering Centers of Excellence. The Senior Materials Engineer will support the planning and coordination of required testing, protocols, reports, and analysis necessary for accelerated aging, real time aging, and biocompatibility testing in compliance with global standards and regulatory requirements for all product platforms. The Senior Materials Engineer will also work closely with the regulatory team in support of regulatory submissions for the US FDA and global regulatory notified bodies. The initial focus of responsibilities will be working with the Medical Device Regulations team to support readiness for implementation of the new European Union Medical Device Regulations. As the subject matter expert, the Materials Engineer will also be responsible for keeping internal procedures current to required external standards.
This unique position requires demonstrated skills in the areas of materials engineering and medical device product design and manufacturing knowledge. This individual must be capable and willing to support multiple parallel projects and initiatives and must be capable of creative problem solving using a variety of skills and tools. The Senior Materials Engineer will be responsible for coordinating necessary identified testing through both in-house and outside companies, as appropriate. This role will be responsible for supporting programs in all phases of product life cycle, including early technology development, product development, design transfer, manufacturing, and post market release support. The Senior Materials Engineer is expected to be a resident expert in selection of materials, material analysis and testing, biocompatibility requirements and testing, and/or material, device, and/or product aging.
ESSENTIAL FUNCTIONS OF THE POSITION:.
- Support the selection, testing, and analysis of materials for medical device design applications through all phases of development and product lifecycle
- Support teams in needed knowledge of material chemical, mechanical, and biological interface requirements
- Provide analysis, testing, and reporting to predict and verify the human body response to designed devices
- Contribute to improvement in methods and processes of the product development organization
- Establish understanding of clinical procedures and techniques applicable to AtriCure products
- Has a knowledge of manufacturing methods and capabilities including plastic injection molding, metal stamping, and metal machining, casting, stamping, forming, grinding, etc.
- Operating within design controls incompliance with global medical device and electronics regulatory standards
- Bachelor of Science degree in Materials, Chemical Engineering or equivalent with 4-7 years' experience in industry
- Experience with accelerated aging and reliability models such as Arrhenius, Coffin-Manson, or other
- Experience with ISO 10993 testing and analysis requirements
- Ability to travel 10%
- Strong materials engineering experience with metals, polymers, and electronic systems
- Working knowledge of the effects of sterilization processes on materials
- Strong written and verbal communication skills with project teams and internal customers
- Experience with mechanical/materials testing such as tensile, compression, cyclic fatigue, and reliability
- Ability to coordinate and define testing and analysis of materials in support of failure analysis, reliability assessments, real time and accelerated aging testing, and understanding of the effects of sterilization processes on materials and devices
- Understanding of medical device product development life cycle including needs assessment, technology development, detail design & manufacturing systems development, regulatory requirements, and product verification / validation
- Experience and success working independently and in a team environment
- Experience with data analysis, problem-solving, troubleshooting, engineering analysis, and formal root cause analysis
- Familiarity with (preferred, but not required):
- Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485
- External Standards, Design controls, Quality controls, Manufacturing methods
- ISO 10993, ISO 11607, ASTM F1980
- Statistical methods
- MS in Materials Science or Engineering, Chemical Engineering, Biomedical Engineering, or equivalent
- Experience in Materials Science for medical device development
- Track record of managing technical development tasks exhibiting comprehensive planning and thorough communication
- Excellent understanding of medical device industry regulations and PMA/510(k) medical device development
- Ability to regularly walk, sit, or stand as required
- Ability to occasionally bend and push/pull
- Ability to regularly lift up to 25 pounds, occasionally lift up to 50 pounds
- Ability to pass pre-employment drug screen and background check
AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).
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