Sr. Product & Engineering Analyst

Align Technology, Inc.; San Jose (CA); On-site; USD 133,000 - 222,000; Full time

Job summary

Align Technology, Inc. is seeking a Sr. Product & Engineering Analyst to drive product development roadmap and requirements for Invisalign aligner, Vivera retainer, and related dental products.

You will partner with marketing, software, biomechanical and regulatory teams to define end-to-end systems and ensure compliance with medical device standards. You will lead cross-functional workshops, refine backlogs, and deliver technically actionable plans while shaping Align's product portfolio and

Qualifications

• Bachelor’s degree or higher in engineering, health science, math or sciences.
• 6+ years in product management, business analysis or product development.
• Dental products or medical device experience preferred.
• Strong analytical and problem-solving abilities with requirements gathering skills.

Responsibilities

• Define, prioritize, and execute the product roadmap for Align products across functions.
• Lead cross-functional initiatives with engineering, marketing, regulatory, and quality teams.
• Develop end-to-end requirements, epics, features, and acceptance criteria.
• Own validation through UAT and testing strategies across complex systems.
• Maintain design control documentation and risk management activities.

Skills

Analytical thinking

Requirements gathering

Product strategy

Project management

Communication

Teamwork

Self-motivated

Clinical knowledge

Education

Bachelor’s degree or higher

Job description

Sr. Product & Engineering Analyst

Department: Research & Development

Employment Type: Full Time

Location: US-California-San Jose

Compensation: $161,200 - $221,600 / year

Description

Sr. Product & Engineering Analyst, Product Innovation

Role summary

This position is ideal for experienced product management professionals to join the Product & Engineering Management team in Research & Development as a Senior Product & Engineering Analyst, driving product development roadmap and requirements for Invisalign aligner, Vivera retainer and similar orthodontic and dental products. Partnering with cross-functional teams, including marketing, software engineering, biomechanical engineering, materials engineering, regulatory and quality, you’ll inform product requirements and define end to end systems to result in a deep meaningful competitive product. This role is vital in shaping Align Technology’s product portfolio and overall business success.

Role expectations

• Partner with product managers and engineering stakeholders to define, prioritize, and execute the product roadmap for Align products, translating business strategy and customer needs into technically actionable plans.
• Independently lead small- to medium-scale cross-functional initiatives across new product development, systems enhancements, and continuous improvement, with accountability for technical scope, requirements quality, and delivery readiness.
• Develop deep product, architecture, and systems knowledge to identify, define, and deliver end-to-end technical solutions that address complex business, clinical, and operational needs.
• Elicit, analyze, and derive requirements from stakeholders across product management, clinical, operations, quality, and engineering, converting them into well-structured epics, features, and user stories with clear acceptance criteria.
• Lead cross-functional workshops to define system-level requirements, interfaces, and workflow dependencies, ensuring scalable and compliant solutions for internal and external users.
• Evaluate end-to-end system impacts, technical dependencies, and downstream implications of requirements to inform effort estimation, sequencing, release planning, and implementation risk.
• Own backlog quality and refinement by incorporating stakeholder input, technical constraints, product feedback, and compliance considerations to maintain alignment with business priorities and release objectives.
• Author and maintain core technical documentation, including statements of requirements, work instructions, product specifications, risk inputs, and related design control deliverables, in collaboration with cross-functional stakeholders.
• Own validation of functional requirements by defining test scenarios, acceptance criteria, and user acceptance testing approaches to validate end solution meets intended use and business needs; provide guidance to peers on UAT best practices.
• Apply structured analytical and systems-thinking approaches to resolve technical and programmatic issues in a fast-paced, multidisciplinary development environment.
• Lead implementation and optimization of requirements, traceability, and testing tools, including Aligned Elements, TM4J, and EDMS, to support scalable product development and design control documentation processes.
• Serve as a functional subject matter expert in Design Control and Risk Management, ensuring development activities and documentation align with applicable medical device regulations and standards, including ISO 13485 and FDA 21 CFR Part 820, and representing these areas during QMSR and internal/external audits.
• Lead complaint handling and risk management activities to ensure traceability, data integrity, and closed-loop feedback from post-market inputs into requirements, backlog prioritization, and continuous product improvement.
• Drive process improvements across product development, design control, and risk management workflows to improve quality, efficiency, traceability, and cross-functional execution.
• Ensure compliance across applicable regulatory areas and support FDA, Notified Body, and other regulatory or quality audits, as well as periodic regional regulatory requests for Invisalign, Vivera, and ancillary products.

What we're looking for

• Education: Bachelor’s degree or higher in engineering discipline, health science, math or sciences or a related field.
• Experience: 6+ years of product management, business analyst or product development experience, Dental Products or Medical Device experience preferred.
• Skills: Strong analytical and problem-solving abilities; demonstrated proficiency in requirements gathering, defining product specifications and product strategy. Basic project management skills for research projects.
• Communication: excellent presentation and communication skills, proven ability to provide technical details while tailoring high-level summaries to suit the needs of different audiences.
• Teamwork: Ability to work both independently and collaboratively. Foster a culture of innovation, collaboration, and continuous improvement.
• Self-motivated, self-starter willing to work through ambiguity and strive for continuous improvement.
• Desire and willingness to develop deep clinical understanding of Invisalign products, dentistry and orthodontics.