Product Research Engineer
Align Technology - Santa Clara, CA

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A member of the R&D Biomechanical Engineering team, the Product Research Engineer conducts independent research of dental product performance, designs and develops product prototypes, conducts both benchmark and computer simulation studies of product performance, and is responsible for data interpretation and study protocol documentation. The Engineer identifies areas of product improvement and initiates feasible studies. The successful candidate is a creative and innovative thinker, motivated by curiosity with a proven record of accomplishments.

ESSENTIAL DUTIES AND RESPONSIBILITIES
  • Work independently at the laboratory bench to develop and evaluate new products/solutions or to adapt and improve existing ones.
  • Design product prototypes with biomechanical test models. Simulate real world conditions and measure outputs using sensors etc.
  • Work with software team to utilize force/moment modeling software. Conduct FEA analysis on computer models that simulate actual conditions.
  • Strong mechanical aptitude and ability to master complex systems with sound mechanical principles.
  • Define procedures to evaluate product performance and conduct bench top testing. The testing may cover efficacy, reliability, verification, and validation.
  • Statistical data analysis and interpretation. Document test protocols in accordance with FDA regulations.
  • 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.
  • Work in a fast paced environment and meet critical deadlines.

ADDITIONAL RESPONSIBILITIES

Other duties may be assigned.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Excellent laboratory skills. Self-motivated with hand-on approach to engineering studies
  • Team player, strong communication skills, both written and verbal.
  • Excellent problem-solving skills, thoroughness, attention to detail.

The main responsibilities are completing assigned tasks to develop custom orthodontic products. These include: the creation and evaluation of prototypes, design characterization, and producing and maintaining the requisite FDA/ISO documentation. Duties will also include general engineering support in R&D.

EDUCATION and/or EXPERIENCE
  • BS in Mechanical or Biomedical Engineering preferred. BS or MS in other scientific disciplines considered.
  • At least 3-5 years experience in product development in the medical device industry preferred.
  • Experience with 3-D modeling using SolidWorks 2005 or later.
  • Knowledge of rapid prototyping processes is preferred.

PHYSICAL DEMANDS & WORK ENVIRONMENT

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
  • Physical Demands: While performing the duties of this job, employee is occasionally required to stand, walk, sit, and use hands to handle objects and tools; reach with hands and arms, talk and hear. Employee must occasionally lift and/or move light to moderate weight. Specific vision abilities required by the job include close vision and the ability to adjust focus.
  • Work Environment: The noise level and temperature in the work environment is usually moderate.

WORK SCHEDULE / HOURS

Regular business hours

About this company
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Align Technology, Inc. is a global medical-device company that pioneered the invisible-orthodontics market with the introduction of the...