R&D Engineer III, Core Product

Align Technology; San Jose (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading medical device company in San Jose is seeking an R&D Engineer III. This role involves leading product development projects, designing and evaluating prototypes, and performing rigorous testing in line with FDA regulations. The ideal candidate will have a strong background in biomedical research, solid experience in product development, and proficiency in 3D modeling software. This full-time position offers the opportunity to innovate in the dental and orthodontic industry.

Qualifications

• 5+ years of experience in biomedical research and/or product development.
• Theoretical and experimental background in structural mechanics and/or biomechanics.
• Experience in the medical device industry.

Responsibilities

• Lead product development projects and research projects until product launch.
• Design and evaluate product prototypes with biomechanical test models.
• Perform statistical data analysis and interpretation.

Skills

Biomedical research

Product development

Additive manufacturing

3D modeling

Scripting/programming

Finite element analysis

Education

B.S., M.S., or Ph.D. in Mechanical/Biomedical Engineering

Tools

SolidWorks

Job description

Join to apply for the R&D Engineer III, Core Product role at Align Technology

Overview

Align Technology is the industry leader and innovator in medical devices focusing on revolutionizing the digital dental and orthodontic industry. This role is for an R&D Engineer III, Core Product in our San Jose, CA office. This position is part of a team that helps improve lives through digital dentistry.

Responsibilities

• Lead product development projects and research projects until product launch
• Work independently to develop and evaluate new products and solutions and adapt and improve existing ones
• Design and evaluate product prototypes with biomechanical test models and experimentation
• Design, build, and verify test hardware, software, and systems as needed
• Define and conduct procedures for bench top testing to evaluate product performance, including efficacy, reliability, verification, and validation
• Work with clinical team to conduct pilot studies and other investigations
• Simulate real world conditions and measure outputs using sensors
• Collaborate with diverse, cross-functional teams to incorporate design and features into prototypes
• Understand and master complex systems with sound mechanical principles
• Define procedures to evaluate product performance and conduct bench top testing
• Responsible for ensuring that testing covers efficacy, reliability, verification, and validation
• Perform statistical data analysis and interpretation
• Perform and document work in accordance with FDA/ISO regulations, including test protocols, test results, and other requirements
• Collaborate with manager and cross-functional team in creating product and test plans
• Communicate with professionals in the field at all levels and transition information into product improvement
• Conceive new product and technology development plans
• Work in a fast-paced environment and meet critical deadlines
• Problem-solve issues with attention to detail
• Provide general engineering support in R&D

Qualifications

• B.S., M.S., or Ph.D. in Mechanical/Biomedical Engineering or related field, or equivalent work experience
• 5+ years of experience in biomedical research and/or product development
• Theoretical and experimental background in structural mechanics and/or biomechanics
• Experience with additive manufacturing and rapid prototyping processes for product design and development
• Experience with 3D modeling using CAD software, SolidWorks preferred
• Experience with scripting/programming
• Experience with finite element analysis
• Experience in the medical device industry
• Experience in orthodontics and/or dental industry

Job details

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Engineering and Information Technology
• Industries: Medical Equipment Manufacturing

Pay Transparency

If provided, base salary or wage ranges are the range Align reasonably expects to pay for the posted position. Actual placement depends on skills and experience, plus total compensation and equity. For locations outside the primary location, the base salary range will be adjusted geographically.

For Field Sales roles, the salary listed is base pay only and does not include the applicable incentive compensation plan. A cost of living adjustment may be added to base pay for higher cost areas in the U.S.

Internship hourly rates are a standard pay determined based on the position, location, year in school, degree, and experience.

Privacy and Equal Opportunity

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Equal Opportunity Statement Align Technology is an equal opportunity employer. We provide equal employment opportunities in all practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country of application, and employment eligibility will be verified as a condition of hire.