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
Otros detalles
- Grupo de puestos Biomedical Engineer
- Función del puesto Research & Development
- Tipo de pago Salario
- Indicador de empleo Non Manager