Associate R&D Project Engineer

Job Profile Summary

The Associate R&D Project Engineer will support orthodontic product development by assisting in design, testing, regulatory documentation, and project execution. Working under the guidance of senior engineers, this role will contribute to cross-functional projects, ensuring compliance, quality, and market-driven innovation. This position requires basic project management skills to effectively coordinate tasks within a project plan and ensure alignment across teams. The products being developed and tested are FDA Class I and II medical devices, requiring strict adherence to regulatory and quality standards.

Key Responsibilities:

• Assist in product design, development, and verification activities based on market feedback from orthodontists and customers.
• Support prototype builds using 3D printing technologies, as well as plastic and metal injection molding for component development.
• Perform force testing using mechanical testing equipment and analyze performance data.
• Develop and execute test protocols and reports, ensuring alignment with FDA Class I and II medical device regulatory requirements.
• Create and maintain FDA-compliant Design History Files (DHF) for each project.
• Help develop and maintain project plans, ensuring timely completion while complying with quality and regulatory requirements.
• Utilize basic project management skills to coordinate cross-functional tasks, track project timelines, and ensure key deliverables are met.
• Coordinate design reviews and cross-functional discussions across multiple time zones (Eastern, Pacific, and EU) to ensure alignment with key stakeholders.
• Work with manufacturing, quality, and regulatory teams to meet compliance and performance standards.
• Participate in team meetings, provide project updates, and assist in risk assessment and mitigation efforts.

Qualifications:

• Education: Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• Experience: 0-3 years of experience in product development (internships included).
• Skills:
  • Basic knowledge of CAD software (SolidWorks preferred).
  • Experience with 3D printing and injection molding (plastic & metal) for prototype development.
  • Familiarity with mechanical force testing equipment (Instron, universal testing machines, etc.).
  • Understanding of mechanical design principles and material properties.
  • Strong organizational and project management skills to coordinate tasks effectively within a project plan.
  • Excellent communication skills to engage with global teams across different time zones.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit; use hands and reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop or kneel. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

Physical Activities:

This position will be working in an office environment, utilizing typical office equipment.

Henry Schein, Inc.is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

For more information about career opportunities at Henry Schein, please visit our website at: www.henryschein.com/careers