Biomechanical Engineer - Shoulder

The Product Development Lead is responsible for leading the development of Zooly’s shoulder product strategy and translating unmet surgical needs into clinically relevant, technically feasible, and commercially meaningful product solutions. This role serves as the primary bridge between surgeons, product development, engineering, clinical, quality, and regulatory teams. The lead defines user needs and product requirements, guides surgeon design activities, shapes clinical workflows and product concepts, and drives product decisions throughout the development lifecycle. The ideal candidate brings strong shoulder orthopaedic domain knowledge, product development experience, and the ability to lead multidisciplinary teams from early concept and feasibility through verification and validation, clinical evaluation, regulatory submission, and product launch. About Zooly

Zooly Labs is on a mission to make advanced surgical guidance more accessible for joint replacement surgery., * 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.
• Contribute to FDA Pre-Submission activities and 510(k) submission preparation by providing product, clinical, technical, and validation content.
• Support investor, strategic partner, and surgeon discussions related to the shoulder product portfolio.
• Maintain the shoulder roadmap, research questions, experiment backlog, and product decision log., * Clear shoulder product requirements and research plan.
• Evidence-based surgeon feedback and design-lab decisions.
• Validated clinical/biomechanical rationale for core features.
• Well-prioritized pod backlog connected to platform engineering deliverables.

How This Role Coordinates

This role works closely with the Senior Systems Engineer and Mechatronics Engineer in the Zooly Shoulder Pod. The Product Development Lead owns the problem definition and clinical interpretation; the Senior Systems Engineer owns system architecture; the Mechatronics Engineer supports hands-on execution. xrbllit The role also collaborates closely with Zooly Platform Engineering to align requirements and integrate shared software, electrical, embedded, mechanical, data, and test capabilities.

• 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.
• Experience translating voice-of-customer and surgeon feedback into user needs, design inputs, measurable requirements, acceptance criteria, and product priorities.
• Experience planning and leading cadaver labs, design labs, bench studies, or clinical workflow evaluations, including experimental design, data interpretation, and actionable follow-up.
• 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.
• Experience with surgical navigation, robotics, smart instruments, intraoperative sensing, digital surgery, or AI-enabled decision-support products.
• Demonstrated experience establishing clinically meaningful performance metrics, ground truth, and validation strategies for sensor- or algorithm-enabled products.
• Experience supporting FDA 510(k) strategy, pre-submission activities, clinical evidence generation, human factors/usability, or product claims development.
• 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.
• Familiarity with technical computing and analysis tools such as Python, MATLAB, C/C++, or equivalent; ability to analyze experimental data and automate engineering workflows.
• Experience with IMUs, force/pressure/strain sensors, wireless modules, and data-acquisition systems.
• Familiarity with machine learning development workflows, including data preparation, model training, validation, and performance evaluation. Proficiency in Python and experience with common machine learning and data analysis libraries such as scikit-learn, PyTorch, TensorFlow, Pandas, or similar tools is preferred.

Zooly is an early-stage orthopaedic technology company building a scalable platform across hip, knee, and shoulder procedures. By bringing together orthopaedic expertise, sensing, and AI, we aim to create a new generation of smart surgical tools that can support surgeons from intraoperative assessment through surgical execution. Our vision is to make intelligent surgical guidance practical across hospitals and surgical settings and ultimately help improve the consistency, precision, and confidence of joint replacement procedures.