AtriCure is a medical device company and a leader in developing, manufacturing and selling innovative cardiac surgical ablation systems designed to create precise lesions in cardiac tissue for the treatment of atrial fibrillation, and systems for the exclusion of the left atrial appendage. Cardiothoracic surgeons are adopting our ablation products for the treatment of AF during concomitant open-heart surgical procedures and sole-therapy minimally invasive procedures. AF affects more than 5.5 million people worldwide and predisposes them to a five-fold increased risk of stroke. Our Synergy Ablation System is the first and only device approved by the FDA for the treatment of Persistent and Longstanding Persistent forms of Afib in patients undergoing certain open concomitant procedures.
We are seeking a Senior Biomedical Engineer in Product Development.
This is a technical position assuming 7+ years in the medical device arena.
A Biomedical Engineering Degree or equivalent is required.
The job performance requires advanced technical abilities, knowledge of life / medical sciences, healthcare practices and procedures, as well as an understanding of product design and development methodologies. Expectation is that the Engineer will have proficiency in computer communication tools (i.e. Microsoft Office products), ability to manage clinical / procedural research activities, fostering and developing Key Opinion Leaders partnerships, scheduling (Microsoft Project), design documentation, and documentation of intellectual property. This position is with a Medical Device company, thus experience in the area of FDA and Regulatory requirements and Standards are preferred.
Application instructions are at bottom of posting.
ROLES AND RESPONSIBILITIES:
- Manage and lead clinical lab activities related to new product development, including animal research studies and procedure development.
- Design, develop, and test all aspects of medical / surgical components, equipment, and instruments.
- Perform analysis related to the design, development, and implementation of surgical instruments for products.
- Demonstrated understanding of the design of medical devices including, design, testing and analysis, verification and validation.
- Development of training materials for communication with external partners.
- Foster partnerships with Key Opinion Leaders to analyze product performance and publish findings.
- Guide the creative development of procedural steps and tool requirements to facilitate increasingly less invasive surgical treatment.
- Understanding of Program Management tools and expectations of Medical Device Design Controls.
- Experience generating and documenting intellectual property.
EDUCATION AND EXPERIENCE REQUIREMENTS:
- Biomedical engineering degree (or equivalent) and 7 years’ experience in biomedical engineering minimum.
- Requires solid understanding of:
- Industry regulations as it pertains to medical devices
- External Standards, Design controls, Quality controls, Manufacturing methods
- Anatomy, physiology, and biophysics
- Leading clinical lab activities.
- Surgical procedure development
- Requires track record of:
- Generating and documenting intellectual property
- More in depth or creative approach to problem solving
- Capable of prioritizing tasks and provide a timely schedule of completion.
- Development of advance surgical procedures and techniques, and associated instruments through Key Opinion Leaders
- Capable of leading animal research studies and procedure development
- Provided with broad tasks and minimal supervision
- May mentor more junior engineers
- Demonstrated proficiencies of communicating best practices
- Requires understanding of complete development horizon including needs assessment, technology development, detail design & manufacturing systems development, regulatory requirements, and product verification / validation.
- Must be proficient acting in and leading integrated process teams, as well as coordinating and communicating customer requirements.
- Excellent written and oral communication skills.
- Solid understanding of external standards, design controls, quality controls, manufacturing methods.
For immediate consideration, please apply online: http://www.atricure.com/biomedical-engineer