Device Engineer II

Role: Support the development and testing of combination drug delivery devices, including prefilled syringes, auto-injectors, and on-body injectors, in a regulated environment. Objectives: Assist in design, verification, and validation activities to ensure device performance and compliance with design controls (21 CFR 820, ISO 13485). Responsibilities: Develop CAD models and drawings, perform physical testing (injection force, dose accuracy), support test method validation, evaluate device components, participate in root cause investigations, and contribute to technical documentation for regulatory submissions. Requirements: BS in Mechanical or Biomedical Engineering; 0-2 years experience in medical device or biotech, with a solid foundation in engineering principles, mechanical design, and fluid dynamics. Skills: Hands-on lab experience, ability to follow protocols, effective communication, and team collaboration. Preferred: Familiarity with design controls and regulatory standards. HighValue: Medical device development (drug delivery systems), regulated environment, cross-functional teamwork, early-career stage, no specified travel or remote work.