Job Summary:
Align Technology is a leader in the dental industry, seeking a Product & Engineering Manager to drive product development strategy for their orthodontic products. The role involves collaborating with cross-functional teams to define product vision and requirements, ensuring compliance with regulatory standards, and leading innovation in the product line.
Responsibilities:
โข Define, communicate and drive the product vision and roadmap for hardware-based products, aligning with company goals and customer needs.
โข Provide technical direction and decision-making across prototyping/feasibility, verification & validation phases of product development.
โข 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.
โข 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.
โข 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).
โข 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.
โข Monitor product development and risk management processes and identify areas for improvement and implementation of industry best practices.
โข Conduct post-launch monitoring for products to track complaints and identify areas for continuous product improvements.
โข 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.
โข Applies creative problem-solving to overcome technical and programmatic obstacles in a fast-paced, multidisciplinary environment.
Qualifications:
Required:
โข Bachelorโs degree or higher in engineering discipline, health science, math or sciences or a related field.
โข 6+ years of product management or product development experience.
โข Strong analytical and problem-solving abilities.
โข Proficiency in requirements gathering, defining product specifications and product strategy.
โข Basic project management skills for research projects.
โข Excellent presentation and communication skills.
โข Proven ability to provide technical details while tailoring high-level summaries to suit the needs of different audiences.
โข Ability to work both independently and collaboratively.
โข Self-motivated, self-starter willing to work through ambiguity and strive for continuous improvement.
โข Desire and willingness to develop deep clinical understanding of Invisalign products, dentistry and orthodontics.
Preferred:
โข Dental Products or Medical Device experience preferred.
Company:
Align Technology, Inc. designs, manufactures, and markets the invisalign system for treating malocclusion or the misalignment of teeth. Founded in 1997, the company is headquartered in Tempe, USA, with a team of 10001+ employees. The company is currently Late Stage.