This position is ideal for mid to senior level product management professionals to join the Product & Engineering Management team in Research & Development as a Product & Engineering Manager, driving product development strategy and roadmap for Invisalign aligner and Vivera retainer products. Partnering with cross-functional teams, including marketing, software engineering, biomechanical engineering, materials engineering, regulatory and quality, you'll create a vision for the product line and inform product requirements to result in a deep meaningful competitive product. This role is vital in shaping Align Technology's product portfolio & vision strategy and overall business success. * Define, communicate and drive the product vision and roadmap for hardware-based products, aligning with company goals and customer needs. * Provide technical direction and decision-making across prototyping/feasibility, verification & validation phases of product development. * Leads cross-functional development of hardware and software solutions in partnership with engineering teams (biomechanical, materials, process, software) with system-level thinking to ensure successful product delivery from concept to launch. * Partner with cross-functional teams, including Marketing, Operations, Quality, Regulatory, and Clinical, to define, prioritize, and validate product requirements and ensure alignment with business and compliance objectives. * Support cross functional project teams as subject matter expert (SME) in Design Control and Risk Management ensuring that product development lifecycle complies with medical device regulatory standards (e.g., ISO 13485, FDA 21 CFR Part 820). * Champions innovation and differentiation in the hardware product line by analyzing market trends, competitor devices, and emerging technologies to identify opportunities for meaningful product improvement. * Monitor product development and risk management processes and identify areas for improvement. * Conduct post-launch monitoring for products to track complaints and identify areas for continuous product improvements. * Ensure compliance with regulatory areas and support FDA, Notified Bodies and other regulatory/quality audits and provide support for periodic regional regulatory requests for Invisalign, Vivera and ancillary products as needed. * Applies creative problem-solving to overcome technical and programmatic obstacles in a fast-paced, multidisciplinary environment.