Senior Biomedical Engineer

POSITION SUMMARY:

This position will contribute to the development of ablation products that treat atrial fibrillation, Left Atrial Appendage (LAA) Exclusion System products, and/or CryoNB products. Job performance requires application of technical abilities, command of life/medical sciences, healthcare practices and procedures, and a solid understanding of product development methodologies.  Deliverable outputs include analysis, design, evaluation, production transfer, and documentation of products that meet medical and regulatory guidelines. The Senior Biomedical Engineer will play a technical leadership role in the context of multi-disciplinary teams under the direction of a project manager.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Design, develop, analyze, and test medical/surgical components, equipment, and instruments
• Perform analytical modeling / analysis of new technologies and design implementations in support of achieving clinical outcomes
• Lead clinical laboratory activities related to new product development, including animal research studies and procedure development
• Provide analysis, testing, and reporting to predict and verify the human body response to designed devices
• Define and execute improvement in methods and processes of the product development organization
• Mentor junior staff
• Generate and document intellectual property

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable work performance
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgment
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others
• Additional duties as assigned

BASIC QUALIFICATIONS:

• Bachelor’s degree Engineering or Life Sciences discipline or demonstrated equivalent combination of education, training and experience
• 7 years of experience in biomedical engineering or equivalent field
• Solid understanding of:

• Anatomy, physiology, and biophysics
• Leading in-vitro and in-vivo lab activities
• Medical device design
• Data analysis with statistical methods
• External Standards, Design controls, and Quality controls

• Familiarity with:

• Design Controls standards FDA QSR 21 CFR Part 820 and ISO 13485
• Medical device manufacturing methods
• Cardiac and thoracic surgical procedures and terminology

• A track record of:

• Creative problem solving, prototyping, and troubleshooting
• Prioritizing tasks and producing deliverables per schedule expectations
• Leading teams to successful outcomes
• Leading and reporting laboratory and animal research studies
• Completion of significant and broad tasks with minimal supervision
• Understanding of development life cycle including needs assessment, technology development, detail design & manufacturing systems development, regulatory requirements, and product verification/ validation
• Proficiency acting in and leading integrated process/product teams, as well as coordinating and communicating customer requirements
• Experience and dedication to mentoring more junior engineers
• Excellent written and oral communication skills
• Experience with International Usability Standards and the practical application of Usability Engineering
• Ability to read and create technical specifications, blueprints, and drawings
• Ability to travel 10%

PREFERRED QUALIFICATIONS:

• BS in Biomedical Engineering
• MS in Engineering or Life Sciences discipline
• 10 years of experience in biomedical engineering or equivalent field
• Experience in Materials Science
• Track record of managing technical development tasks exhibiting comprehensive planning and thorough communication
• Excellent understanding of industry regulations as it pertains to medical devices
• Excellent understanding of external standards, design controls, quality controls, manufacturing methods
• Proven track record of generating and documenting intellectual property
• Solid understanding of cardiac and thoracic surgical procedures and terminology
• Familiarity with project management methods and tools for planning, executing, and reporting results
• Experience in collaborating with Marketing and Sales disciplines, including establishing and maintaining customer relationships

OTHER REQUIREMENTS: 

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed
• Ability to regularly lift up to 25 pounds, occasionally lift up to 50 pounds
• Ability to pass pre-employment drug screen and background check

#LI-RD1