Staff R&D Engineer, Clinical

The Job Opportunity:

The Clinical Engineer uses in-depth knowledge of anatomy and biomechanics to work with design engineers and clinicians to develop safe and highly effective new products and upgrades to existing products for our neuromodulation systems platform. The Engineer is responsible for establishing data-driven customer requirements, validating customer requirements to ensure a high-quality patient outcome, and conveying clinical value throughout the organization, including demonstrating that products meet their intended use within the defined use environment. The Clinical Engineer is also responsible for leading risk assessment activities as well as usability initiatives across product/organizational lines.

The Job Responsibilities:

• Support development of customer, system, and product requirements.
• Assess and document clinical design risks and advise the team on risks and mitigations.
• Develop, plan, execute, analyze, and document experiments, and draw relevant conclusions.
• Develop Design Validation Plans, Protocols & Reports. Conduct preclinical validations and design iteration assessments of products both internally and with external key opinion leaders.
• Conduct formal validation testing for new products, product updates, and modifications to existing designs, to ensure the clinical safety and efficacy of the product.
• Develop/modify clinical workflows and facilitate the transition of new/updated technology and features into products through clinical review and evaluation.
• Leverage clinical and product expertise to aid new concept and product development and evaluate the compatibility of system components in clinical workflow scenarios.
• Plan and conduct worldwide customer, competitive, and software industry research to identify and prioritize usability improvement possibilities and solutions.
• Organize and manage work to deliver usability deliverables on programs.
• Prioritize tasks by distinguishing urgent from important tasks and assessing cost/benefit trade-offs.
• Develop an understanding of the scientific, technical, medical, and clinical aspects of company devices and features and the disease states they aim to treat.
• Support clinical evaluation of new or enhanced products. Identify potential product enhancements and new product ideas by applying an analytical approach to understanding the clinical needs of physicians.
• Maintain a detailed understanding of the developing clinical environment (e.g., current treatment methods, evolving clinical needs, etc.).
• Maintain a detailed understanding of the company, FDA 21 CFR Part 820, and ISO regulations.

Required Qualifications:

• Bachelor’s degree in Biomedical Engineering, Biochemistry, Biology, Chemistry, or related field.
• 8+ years’ experience in medical device-related R&D or other highly regulated industries.
• Experience gathering user needs and defining customer requirements.
• Experience generating data-driven justifications for requirements, including designing, and executing testing needed to support clinical justifications.
• Experience working in teams that design devices to meet user needs.
• Experience designing and leading preclinical device studies.
• Experience leading technical reviews.
• Experience working with physicians in a clinical environment (OR, ASC, in-office).
• Self-starter needing minimal supervision. Strong verbal and written communication with the ability to effectively communicate at multiple levels within the organization.
• Experience interfacing with a variety of management levels and effectively presenting technical information.

Preferred Qualifications:

• Advanced credentials in a relevant discipline/concentration, including Biomedical Engineering or medical field.
• Experience with modeling software.
• Fluent in surgical terminology and sound knowledge of anatomy and surgical techniques.
• Technical or medical experience in neuromodulation.
• Technical or medical experience with spinal anatomy.
• Experience supporting physician visits.
• Experience supporting clinical testing of devices.