Clinical Research Engineer II

Alphatec Spine•Carlsbad, CA

About The Position

Contribute to the advancement of ATEC’s technologies by supporting functional biomechanics research, clinical validation and scientific evidence generation efforts. Working cross-functionally, this role will support study design and protocol execution, management and analysis of complex multi-modal datasets, and translation of findings into clear technical documentation and scientific communications that demonstrate product value and clinical impact. Essential Duties and Responsibilities Contribute to the development and validation of workflows for emerging objective functional measurement modalities, e.g., wearable sensors, electromyography, computer vision, force plates. Partner cross-functionally to identify evidence gaps and align research studies with product and business objectives. Assist with defining and executing performance testing strategy for clinical validation of ATEC products, including imaging, navigation and robotics technologies. Support the design and execution of clinical research protocols evaluating functional biomechanical assessment methodologies and enabling technology performance. Organize and manage large datasets data from research studies, ensuring accuracy, traceability, and proper documentation. Compile, critically analyze, and interpret research data across multiple data modalities. Prepare clear, complete and accurate technical engineering documentation. Contribute to the dissemination of scientific findings through presentation and writing for both internal and external audiences, including interim reports, conference abstracts, presentations, manuscripts, product/procedural training and collateral; assist investigators or customers in the preparation and delivery of research results. Collaborate closely with other members of the Scientific Affairs team, through meetings and interactions to gather technical and clinical support as well as to ensure alignment of the research activities within the team. Work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercise judgment within defined procedures and practices to determine appropriate action. Normally receives general instructions on routine work, detailed instructions on new projects or assignments. Requirements The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requirements

Experience with data‑processing tools and analytical workflows, including scripting and automation (MATLAB, Python, Excel).
Superior problem-solving skills with a solid understanding of scientific research and analytical methods.
Knowledge of standards and regulatory requirements at intersection of clinical data and medical imaging; FDA CDRH guidance documents,
Knowledge, understanding, and application of the conduct of clinical investigations involving humans in accordance ICH/GCP, US Code of Federal Regulations (CFR), and the ethical principles that guide clinical research consistent with the principles of the Nuremberg Code, the Belmont Report and the Declaration of Helsinki;
Strong technical writing skills with ability to communicate results to internal and external customers.
Familiarity with electronic data capture systems (EDC, EMR), data analysis, and data visualization.
Experience in technical writing, peer-reviewed literature retrieval and publishing.
Detail-oriented, resourceful problem solver, with effective organizational skills.
Ability to work in a fast-paced environment.
Master of Science degree in biomedical engineering with at least 2 years of experience
For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

Nice To Haves

Knowledge of orthopedics research, particularly spine, is a plus

Responsibilities

Contribute to the development and validation of workflows for emerging objective functional measurement modalities, e.g., wearable sensors, electromyography, computer vision, force plates.
Partner cross-functionally to identify evidence gaps and align research studies with product and business objectives.
Assist with defining and executing performance testing strategy for clinical validation of ATEC products, including imaging, navigation and robotics technologies.
Support the design and execution of clinical research protocols evaluating functional biomechanical assessment methodologies and enabling technology performance.
Organize and manage large datasets data from research studies, ensuring accuracy, traceability, and proper documentation.
Compile, critically analyze, and interpret research data across multiple data modalities.
Prepare clear, complete and accurate technical engineering documentation.
Contribute to the dissemination of scientific findings through presentation and writing for both internal and external audiences, including interim reports, conference abstracts, presentations, manuscripts, product/procedural training and collateral; assist investigators or customers in the preparation and delivery of research results.
Collaborate closely with other members of the Scientific Affairs team, through meetings and interactions to gather technical and clinical support as well as to ensure alignment of the research activities within the team.
Work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
Exercise judgment within defined procedures and practices to determine appropriate action.
Normally receives general instructions on routine work, detailed instructions on new projects or assignments.