Staff R&D Clinical Engineer

As the R&D Staff Engineer, you will be part of our EP product development team focused on delivering the future in implantable atrial devices, and diagnostic, imaging, and ablation therapy catheters and EP capital equipment. This role will involve a range of responsibilities including but not limited to requirement development, testing and data analysis, validation testing, and serving as a clinical consultant on clinical workflows and risk evaluation documentation.

What You'll Work On

• Provide feedback and insight on clinical workflows and clinical use of EP products.
• Support development of risk management documentation.
• Design, conduct/supervise, and support bench and preclinical studies for product concept feasibility and formal regulatory submission.
• Plan, coordinate, and conduct empirical and experimental analysis. Organize and analyze data from experiments or design builds and write reports on results.
• Conduct research and prepare research tasks.
• Document work suitable for technical papers and patents.
• Participate in project design reviews and project planning. Track performance against plan. Develop plan in conjunction with technical supervisor.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Perform other related duties and responsibilities, on occasion, as assigned.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, biological sciences, or equivalent experience.
• Minimum 8 years progressively more responsible work experience in related engineering field.
• Experience in preclinical testing methods including GLP study experience.
• Experience working within a team and as an individual contributor in a fast-paced, changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels of the organization.
• Strong organizational and follow-up skills, as well as attention to detail.
• Strong technical and interpersonal skills.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to leverage and/or engage others to accomplish projects.
• Ability to multitask, prioritize and meet deadlines in timely manner.

Preferred Qualifications

• Design Validation and GLP study experience in the medical device industry.
• Experience with cardiac devices.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to plan, execute, analyze, and document individual scientific studies.