Responsible to lead and support the design, prototyping, evaluation, and advancement of R&D projects to develop new devices and improve existing devices. Provide guidance on the use and usability of the Company’s products, anticipating and proactively addressing customer and clinical study needs to advance both near-term and long-term device solutions. Provide field clinical engineering expertise, education, and training to support clinical and commercial cases.

Work with internal and external team members, physicians, and subject matter experts to review and analyze data, assess opportunities, advance new product concepts, generate requirements, develop designs, lead and support device testing, support pre-clinical and clinical evaluations, and transfer to Engineering and Manufacturing new products, and provide expert support throughout the product life cycle.  

Responsibilities

• Lead R&D projects in coordination and communication with other internal and external team members to develop new products and improve existing products to meet the needs of the Company and its customers.
• Provide field clinical engineering support for clinical studies and commercial use and evaluate the feasibility, efficacy, safety, and overall performance of new and existing neurostimulation systems, devices, and components.
• Support education and training of the Company’s staff and education and training of clinicians and their staff in the use of the Company’s products; and provide expertise and guidance on the use of the Company’s products in new or challenging cases.
• Provide expert R&D support as part of a multidisciplinary team, serving as a liaison as needed to other Departments including the Engineering, Quality, Regulatory, Marketing, and Sales teams to ensure new products and improvements transition effectively from early-stage concepts to consistent successful use in the field.
• Receive, summarize, and communicate input from experiences in the field to internal team members, indicating potential relevance to existing products and new products in development.
• Develop and execute project plans, timelines, budgets, milestones, and deliverables in coordination with other subject matter experts and cross functional team members such that the resulting product meets the needs, resources, and timing of the Department and the goals of the Company.
• Identify product needs, problems, and solutions; perform analysis; generate designs, tests, and documentation; support requirements; and advance projects through the product development life cycle, providing leadership during the Research phase, including but not limited to concept generation, prototyping, testing, refinement, and transition to the later phases of Development and providing expert support throughout the later phases including product launch, clinical and commercial use, usability, and further refinement as needed.
• Support education and training, scientific and clinical publication, presentation, and literature review efforts and advance protocol development, grant and contract proposal development, and messaging efforts in coordination with internal and external members of a multidisciplinary team.
• Support efforts to obtain extramural funding (e.g. grants, contracts, etc.) to advance R&D projects.
• Effectively work within a team of various Departments (e.g., Engineering, Manufacturing, Regulatory, Quality, Clinical Affairs, Marketing, Sales, and R&D) as necessary to achieve the objectives of the Department and the goals of the Company, all within a given timeframe and budget.
• Develop new and strengthen existing relationships with subject matter experts, key opinion leaders, and external and internal team members.
• Responsible to work within the company’s formal design control and quality management system, including applicable policies and procedures.
• Interface directly with key opinion leaders, key customers, end-users, and team members in the coordination and generation of product requirements and specifications and in the education of the use of the Company’s products.
• Identify and develop intellectual property critical to the success of new neurostimulation products. 
• Provide training and mentorship and serve as an active resource for others within the R&D Department and across the Company.

• MS or higher in Biomedical Engineering or a related field. Neurostimulation experience preferred.
• Experience analyzing scientific data, reviewing literature, and supporting generation of grant and/or contract proposals, project plans, and design and development of medical devices.
• 3+ years of experience educating and training clinicians and staff on the use of medical devices, delivery of therapeutic electrical stimulation, and field clinical engineering support of neurostimulation devices with physicians and patients. Experience in both the commercial and clinical research context preferred.
• Proficient in statistics, electronic circuits, electrical and mechanical testing equipment, engineering and manufacturing documentation and processes, test protocol development, and computer-aided design (CAD) software.
• 5+ years of combined experience in electrical stimulation medical device industry or related biomedical field.
• Familiar with standard medical industry documentation methods such as bill of materials, component specifications documents, hazard / risk assessment processes, FMEA, etc.  

Working Conditions

• Strong self-starter, who is also an effective team player, with consensus building skills.
• Ability to work comfortably within a development team to lead activities in one phase or activity and support the efforts of others in another phase or activity. 
• Ability to work efficiently and creatively in a regulated industry.
• Comfortable in a start-up environment, but willing to grow into a larger formalized organization.
• Ability to effectively work in a “virtual environment” at a home, remote, or centrally located office and while traveling.
• Willing to travel to support clinical and commercial use of devices and meet with key opinion leaders, customers, and internal and external team members.
• Must be an effective communicator and be able to lead meetings and present projects. 

Why Join Our Team?

• Voted Top Workplace 
• Competitive salary with company-paid medical, dental, and vision benefits
• Entrepreneurial work environment – A high growth oriented and collaborative atmosphere in the medical device industry!
• Data-driven and outcome-focused
• Opportunity to work with game changing equipment/technology.
• Passion for improving the lives of millions of pain sufferers