Hiring: Biomechanical Engineer - Shoulder Company: Zooly Labs, Inc Location: Boulder, CO Job Posted Time: 2026-09-11 12:53:52 Target Skills & Keywords : C, C++, Embedded Systems, MATLAB, Machine Learning, Pandas, Product Strategy, PyTorch, Python, Risk Management, TensorFlow, scikit-learn About the job Experience: •7+ years of experience in orthopaedic medical devices, surgical robotics/navigation, biomechanics, sensor-enabled devices, or closely related product development; equivalent combinations of advanced education and industry experience will be considered. Required Skills: •Own the shoulder orthopaedic application strategy across Zooly Sense, Solve, and Go capabilities. •Lead surgeon design team meetings, cadaver/design labs, bench studies, and clinical workflow reviews. •Translate surgical needs into user needs, system requirements, research protocols, and product priorities. •Define clinically meaningful outputs, ground truth, acceptance criteria, and interpretation of algorithm results. •Partner with the Senior Systems Engineer on architecture, sensing strategy, integration risks, and verification plans. •Partner with the Mechatronics Engineer on prototypes, fixtures, and design-lab execution. •Lead the joint-specific technical and clinical inputs required for regulatory strategy and FDA submissions, including intended use, product claims, verification and validation evidence, clinical evidence, and responses to regulatory questions. •Support risk management, design controls, human factors, clinical study planning, and quality documentation in collaboration with Regulatory and Quality teams. Qualifications: •Master's degree or PhD in biomedical engineering, biomechanics, robotics, mechanical engineering, or a related discipline, particularly for research-intensive product development. •Typically 7+ years of experience in orthopaedic medical devices, surgical robotics/navigation, biomechanics, sensor-enabled devices, or closely related product development; equivalent combinations of advanced education and industry experience will be considered. •Demonstrated ability to lead product development from unmet clinical need and concept definition through prototyping, verification/validation, design transfer, and clinical or regulatory readiness. •Strong working knowledge of orthopaedic anatomy, biomechanics, implant/instrument workflows, and the ability to engage credibly with surgeons and key opinion leaders. •Solid functional working knowledge of medical-device design controls, risk management, verification/validation, and cross-functional product development in an FDA-regulated and/or ISO 13485 environment. •Strong leadership, technical judgment, written communication, and presentation skills, with the ability to influence across engineering, clinical, quality, regulatory, manufacturing, and external partners. •Direct experience in anatomic or reverse shoulder arthroplasty, shoulder biomechanics, stability/impingement, implant positioning, navigation, or shoulder instrumentation. •Demonstrated experience establishing clinically meaningful performance metrics, ground truth, and validation strategies for sensor- or algorithm-enabled products. •Track record of successful product launches, patents, peer-reviewed publications, clinical collaborations, or technology transfer from research into commercial products. •Startup or early-stage product experience, including comfort with rapid iteration, ambiguity, resource constraints, and hands-on problem solving. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!