Sr. R&D Engineer, Products

Description

We are seeking a Sr. R&D Engineer, New Products to lead the research, design, development, and launch of innovative medical devices from concept through commercialization. In this role, you will partner closely with cross‑functional teams across R&D, Product Management, Clinical, Quality, Regulatory, and Operations to identify unmet needs, evaluate new technologies, develop and test prototypes, and translate insights into robust product solutions.

This is a hands‑on engineering role for someone who thrives in fast‑paced product development environments and enjoys solving complex technical challenges from early feasibility through product launch and post‑launch improvement.

• Lead product development work streams from concept through launch, including planning, execution, and cross‑functional coordination.
• Design, prototype, and evaluate product concepts using biomechanical models, benchtop methods, and experimental testing.
• Develop and execute verification and validation activities to assess product performance and design robustness.
• Design, build, and verify test hardware, fixtures, and systems, including automation tools, as needed to support product development.
• Apply sound mechanical and engineering principles to understand, model, and solve problems involving complex systems.
• Perform statistical analysis and interpret data to guide technical decisions and product improvements.
• Communicate technical findings, recommendations, and product insights effectively to stakeholders at all levels.
• Collaborate with cross‑functional partners to incorporate design inputs, technical requirements, and user needs into product prototypes and final designs.
• Partner with Clinical Affairs and cross‑functional teams to support clinical studies and other product investigations.
• Generate clear, complete technical documentation in compliance with FDA, ISO, and internal medical device development requirements, including protocols, reports, and design documentation.
• Contribute to invention generation, intellectual property development, and patent disclosures.
• Prioritize and execute work effectively in a fast‑paced environment with evolving priorities and critical timelines.
• Provide broad engineering support as needed.

• B.S. in Mechanical Engineering, Biomedical Engineering, or a related field with 8+ years of experience in biomedical research and/or product development.
• M.S. in Mechanical Engineering, Biomedical Engineering, or a related field with 6+ years of experience in biomedical research and/or product development.
• Ph.D. in Mechanical Engineering, Biomedical Engineering, or a related field with 3+ years of experience in biomedical research and/or product development.
• Higher or lower years of experience will be considered for this role, with job level and title adjusted accordingly.

• Strong theoretical and experimental background in structural mechanics and biomechanics.
• Experience with 3D CAD solid modeling and mesh‑based modeling tools.
• Test method development, verification, and validation.
• Data analysis, scripting, and automation for experimental and design workflows.
• Additive manufacturing (3D printing) for test fixtures, prototypes, and end‑use product applications.
• Experience in the medical device industry.

If provided, base salary or wage rate ranges are the range in which Align reasonably expects to set a candidate’s pay for the posted position. Actual placement depends on the individual skills and experience level of a candidate plus the total compensation and equity across team members. For other locations outside of the primary location, the base salary range will be adjusted geographically.

We are pleased to provide a general description of the benefits Align offers to full‑time employees in this position.

• Medical, dental, and vision coverage with a Health Savings Account option for some plan offerings.
• Discounts on Invisalign and Vivera to employees and their eligible dependents after 90 days of employment.
• Back‑up Child/Elder Care and access to a caregiving concierge.
• Family Forming Benefits – Available to Employees, and their…