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· Perform physical testing of drug delivery devices (e.g., injection force, injection time, dose accuracy) using lab equipment such as Instron or Zwick systems.
· Set up, execute, and document testing activities in accordance with protocols and Good Documentation Practices (GDP).
· Support the development, verification, and validation of test methods under the guidance of senior engineers.
· Assist in the evaluation of device components (e.g., stoppers, barrels, springs) for fit, function, and quality.
· Participate in basic root cause investigations of product or test method deviations.
· Contribute to technical reports, data summaries, and documentation for design verification and regulatory submissions.
· Collaborate with cross-functional teams including QA, Regulatory, and Manufacturing to support development activities.
· Learn and apply relevant quality and regulatory standards (e.g., ISO 13485, ISO 14971, 21 CFR Part 820) in daily work.
Required Qualifications
· BS in Mechanical Engineering, Biomedical Engineering or a related field
· 0-2 years Medical Device or Combination Product experience
· Strong academic foundation in engineering principles and an interest in medical device or drug delivery systems including a good foundation in solid mechanics, mechanical design and fluid dynamics..
· Some hands-on lab experience (academic, co-op, or internship) with physical testing or mechanical systems.
· Ability to follow protocols and standard operating procedures.
· Effective written and verbal communication skills.
· Eagerness to learn in a collaborative and regulated environment.
Preferred Qualifications:
· Internship or cooperative experience in the pharmaceutical, biotech, or medical device industry.
· Exposure to regulated environments or quality systems (e.g., ISO 13485, GMP).
· Familiarity with Microsoft Excel, basic statistical tools, or mechanical test instruments.
· Experience in mathematical modeling and finite element analysis
· Experience in statistical analysis for medical devices
We offer a competitive benefits package, including:
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