Shoulder Biomechanics Product Lead

Zooly Labs, Inc; Boulder (CO); On-site; USD 180,000 - 240,000; Full time

Job summary

Zooly Labs, Inc. is seeking a Product Development Lead to guide the shoulder product strategy from concept to launch.

You will bridge surgeons, product development, engineering, clinical, quality, and regulatory teams to translate unmet clinical needs into feasible, meaningful solutions. The ideal candidate has strong orthopaedic domain knowledge and proven leadership to drive multidisciplinary programs from early feasibility through verification, validation, regulatory submission, and

Qualifications

• Master's degree or PhD in biomedical engineering, biomechanics, robotics, mechanical engineering, or related field.
• Typically 7+ years of experience in orthopaedic medical devices, surgical robotics/navigation, biomechanics, sensor-enabled devices, or related product development.
• Proven ability to lead product development from unmet clinical need through prototyping, verification/validation, and regulatory readiness.
• Strong working knowledge of orthopaedic anatomy, biomechanics, implant/instrument workflows, and surgeon engagement.
• Experience translating surgeon feedback into user needs, design inputs, measurable requirements, and priorities.
• Experience planning and leading cadaver labs, design labs, bench studies, or clinical workflow evaluations.
• Familiarity with medical-device design controls, risk management, verification/validation, and cross-functional development in FDA/ISO environments.
• Strong leadership and cross-functional communication to influence engineering, clinical, regulatory, manufacturing.

Responsibilities

• Own the shoulder orthopaedic application strategy across Zooly Sense, Solve, and Go capabilities.
• Lead surgeon design team meetings, cadaver 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 engineers on architecture, sensing strategy, and verification plans.
• Lead regulatory inputs for FDA submissions and quality documentation.
• Maintain shoulder roadmap and project backlog.
• Support investor and partner discussions related to the shoulder portfolio.

Skills

Leadership

Cross-functional collaboration

Written and verbal communication

Regulatory knowledge

Strategy development

Education

Master's or PhD in biomedical engineering / related field

Tools

Python

MATLAB

C/C++

ML frameworks (scikit‑learn, PyTorch, TensorFlow)

Job description

Zooly Labs, Inc. is seeking a Product Development Lead to guide the shoulder product strategy from concept to launch.

You will bridge surgeons, product development, engineering, clinical, quality, and regulatory teams to translate unmet clinical needs into feasible, meaningful solutions. The ideal candidate has strong orthopaedic domain knowledge and proven leadership to drive multidisciplinary programs from early feasibility through verification, validation, regulatory submission, and