How Youβll Spend Your Day:
- Support or lead combination product development under design controls (user needs, inputs/outputs, traceability, risk management, verification planning, test protocols/reports, design history file).
- Develop/execute/document engineering studies and statistically sound test strategies for device performance, robustness, manufacturing variation, and lifecycle changes.
- Perform hands-on testing/characterization of device + container-closure systems (injection force, break-loose/glide/extrusion force, injection time, dose accuracy, closure integrity, component fit/function).
- Develop/qualify/validate physical test methods and fixtures; use lab equipment/tools (Instron/Zwick, fixtures, microscopy, CT, silicone coating analysis, CAD, statistical tools).
- Lead/support investigations and root cause analyses for deviations, complaints, manufacturing/supplier issues.
- Apply systems/mechanical engineering (solid mechanics, materials, fluid dynamics, tolerance analysis, DFM, modeling/FEM as appropriate).
- Collaborate cross-functionally and prepare technical documentation (protocols, reports, lab records, investigation summaries, verification evidence, change assessments, regulatory submission content).
Your Skills and Experience:
- BS/MS in Mechanical or Biomedical Engineering (or related).
- Approx. 2β4 yrs (Device Engineer II), 4β6 yrs (Senior), 6β8+ yrs (Principal); advanced degrees may offset.
- Foundation in mechanical/solid mechanics/design/materials/fluid dynamics and device performance evaluation.
- Hands-on physical testing/fixture development and component/device characterization.
- Regulated development knowledge (design controls, quality systems, risk management, GxP/Good Documentation Practices; e.g., 21 CFR 820/4, ISO 13485, ISO 14971).
- Data analysis, clear communication, cross-functional collaboration.
- Experience with prefilled syringes/autoinjectors/on-body/wearable/needle safety or other parenteral delivery systems.
- CAD/statistical tools (e.g., SolidWorks, JMP/Minitab), modeling/FEM/first-principles.
- Familiarity with biologics/container-closure interactions and filings (IND/BLA/MAA), human factors/usability, verification and test method validation.