Device Engineer II (Combination Product Development)
Responsibilities:
- Develop detailed 3D CAD models, assemblies, engineering drawings, and testing fixtures (SolidWorks or equivalent) for device development, characterization, verification testing, and manufacturing support.
- Perform physical testing of drug delivery devices (e.g., injection force, injection time, dose accuracy) using lab equipment such as Instron or Zwick.
- Set up, execute, and document testing activities per protocols and Good Documentation Practices (GDP).
- Support development, verification, and validation of test methods under senior engineer guidance.
- Assist in evaluation of device components (e.g., stoppers, barrels, springs) for fit, function, and quality.
- Participate in basic root cause investigations of product/test method deviations.
- Contribute to technical reports, data summaries, and design verification/regulatory submission documentation.
- Collaborate with QA, Regulatory, and Manufacturing.
- Learn and apply quality/regulatory standards (ISO 13485, ISO 14971, 21 CFR Part 820).
Qualifications/Skills:
- BS in Mechanical Engineering, Biomedical Engineering, or related field.
- 0β2 years experience in pharmaceutical, biotech, or medical device.
- Strong foundation in solid mechanics, mechanical design, and fluid dynamics; interest in medical device/drug delivery systems.
- Some hands-on lab experience (academic, co-op, or internship) with physical testing or mechanical systems.
- Ability to follow protocols/SOPs; effective written/verbal communication.
- Eagerness to learn in a collaborative, regulated environment.
- Ability to manage concurrent technical activities and prioritize workload while maintaining quality/compliance.
Benefits (explicitly listed):
- Comprehensive health insurance; 401(k) match/defined contribution; Paid Time Off; company-paid life and disability insurance.
Application:
- Apply via Tevaβs internal career site on Twist.