Intern - Co-op

Posted Mar 6, 2020
Project ID: SHPGJP00004793
Lexington , MA
6 months
(Jul 1, 2020 - Dec 31, 2020)
40 hrs/week
Payrate range
Job Title: Commercial Device Engineering Co-op
The Organization: This is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing better health and a brighter future to people worldwide. Medical Device Center of Excellence in Lexington, MA is a state-of-the-art facility comprised of a dynamic group of engineers who focus on developing delivery devices for the administration of drugs and biologics. The Medical Device team works closely with cross-functional colleagues to develop combination products (delivery device and drug/biologic) to treat conditions in the areas of Oncology,
Rare Diseases, Neuroscience, and Gastroenterology.
The Culture: The culture of the Medical Device group is social, fast-paced, collaborative, and engaging. Colleagues often eat lunch together, attend team outings, socialize outside of work, and create relationships that allow for an effective team atmosphere. The environment allows colleagues to create an extensive network within the pharmaceutical and medical device industries. Our culture
supports growth and development through strong mentorship and manager support; asking questions and seeking out guidance is always encouraged.
The Co-op Student: The co-op student will contribute technical efforts on projects that improve and maintain the health of on-market devices and constituents of combination products. As a hands-on engineering co-op, this student will be responsible for collecting and analyzing product data, planning and assessing study designs, and applying solid scientific principles to the evaluation of product quality
indicators and risk assessment activities for various projects impacting commercial devices in the planning and execution stages. The student will contribute to device product engineering and design control activities, including:
 Supporting Continuous Improvement (CI) and Quality By Design (QbD) design and technology
changes through test method development, qualification, and lab testing
 Understanding user needs, product requirements, and system requirements for on-market
delivery devices
 Supporting complaint investigations with structured problem solving tools and root cause
 Performing Risk Management activities, including Hazard Analysis and Failure Modes and Effects
Analysis (FMEA)
 Operating in a highly-regulated industry and adhering to standards, guidance documents and
 Working with cross-functional partners in Quality, Regulatory, Human Factors, etc. to progress
projects through the post-market lifecycle phase
The student will also have the opportunity to gain additional skills in the course of this co-op, including
(but not limited to):
 Process/method development and measurement system analysis
 Benchtop Testing (including Instron mechanical testing and dimensional metrology)
 Data analysis using statistical techniques and software
The student will have the following required minimum skills:

 GPA of 3.3 or greater preferred
 Eager to contribute and participate in a fast-moving, team-oriented atmosphere
 Strong communication skills (written, verbal, and presentation)
 Ability to self-organize and prioritize multiple responsibilities
 Ability to follow protocols carefully to execute lab tests independently
 Working knowledge of GD&T is preferred
 Prior co-op experience is preferred
 Knowledge about mechanical testing and statistics is a plus
 Past experience in the medical device industry is a plus

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