Salary
💰 $60,000 - $120,000 per year
About the role
- Provide engineering leadership in the creation and development of new medical device products (invasive and non-invasive).
- Research, develop, design test models, and evaluate mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.
- Conduct feasibility studies to verify capability and functionality and develop new concepts from initial design to market release.
- Direct support personnel and coordinate project activities; participate in determining goals and objectives for projects and may lead projects.
- Utilize multidisciplinary engineering knowledge to design and develop innovative new products in the structural heart space.
- Understand user needs and aid in setting appropriate requirements to capture those needs.
- Perform technical planning and performance evaluation studies; evaluate prototypes through structured and ad hoc testing.
- Evaluate customer satisfaction and device performance through end user testing (simulated use, pre-clinical, and/or usability), analysis and studies.
- Provide clinical, usability and system level technical guidance and support to teams; evaluate system user interface and provide input into development of clinical system validation plans.
- Maintain detailed documentation throughout all phases of research and development.
- Investigate and evaluate existing technologies and establish and cultivate an extensive network of support to facilitate completion of assignments.
- Participate in development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel.
- Plan and organize non-routine tasks with approval; initiate or maintain work schedule; establish priorities of work assignments.
Requirements
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or other related engineering field.
- 2+ years of engineering experience, primarily in R&D or clinical engineering.
- Medical device experience (preferred).
- Master’s Degree in Biomedical, Mechanical, or Systems Engineering or equivalent (preferred).
- Experience in a Quality System environment (preferred).
- Baseline clinical knowledge of cardiac function (preferred).
- Demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs (preferred).
- Previous experience working in a highly matrixed and geographically diverse business environment (preferred).
- Knowledge of statistical techniques and design of experiments (preferred).
- Knowledge of human factors engineering (preferred).
- Knowledge of animal models and animal study design (preferred).
- Knowledge of anatomical model development (preferred).