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Engr 2, Validation in Andover, MA at Integrated Resources, Inc

Date Posted: 2/11/2019

Job Snapshot

  • Employee Type:
  • Location:
    Andover, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Job Description Design Validation Intern / Co-op
The Diabetes Care business unit has a long history within Client and is unique in that it focuses on one important disease state which is a threat to world health. The business unit is comprised of approximately 2,300 associates globally. Client s Andover facility focuses on the development of Advanced Diabetes Care products to help patients improve the treatment of their disease and lead healthier lives.

Within the Diabetes Care business, you will have the opportunity to contribute to research and development activities that will have a key impact on the Diabetes Care market. We are looking for a motivated individual that is interested in learning about this market segment and contribute to our product testing activities.

As an engineer in the design validation group you will be responsible for understanding the testing goals necessary to demonstrate that the product meets product requirements. You will work in a cross-functional team setting to identify appropriate preclinical, human factors, and clinical studies, determine appropriate sample sizes for studies, prepare samples, execute testing, analyze data, and write final test reports.

Contribute to design specifications, requirements, dFMEA, DV plan, and documentation in preparation for clinical studies
Support clinical product build and design verification documentation in support of regulatory submission and clinical product release according to Client corporate requirements, FDA requirements, and international quality standards (as applicable)
Test product against requirements using validated test methods
Analyze preclinical, human factors, user, or clinical study data
Support exploratory testing to determine root cause of defective or failed product
Participate in training and execution of testing as needed

Good statistical analysis
Good mechanical test laboratory skills
Strong attention to detail
Good communication skills
Knowledge of clinical and regulatory requirements (preferred)

Bachelors Degree in biomedical engineering, health sciences, or similar program is required.
Experience working in a test laboratory is preferred
Experience working with test equipment (Instron, Pressure testing, Torque measurements, etc.) is a plus
Knowledge of Microsoft Office programs (Word, Excel, PowerPoint) is a must
Knowledge of Matlab or Minitab software programs is a plus