What are the responsibilities and job description for the Verification Validation Engineer position at Intellectt Inc?
Job Title: Verification & Validation Engineer
Location: Marlborough, MA (Onsite)
Key Responsibilities:
- Execute design verification activities for disposable medical devices.
- Support manufacturing methods such as injection molding, tube extrusion, thermoforming, ultrasonic/laser welding, UV gluing, and solvent bonding.
- Conduct test method validation (DOE, OQ, Gage R&R) and perform mechanical testing (pull, peel, burst, leak, dye, bubble tests).
- Lead packaging design validation, transport simulation (ISTA), and stability studies (aging, pre-conditioning).
- Operate within ISO Class 7 & 8 cleanroom standards.
- Apply knowledge of biocompatibility (ISO 10993), extractables & leachables (E&L), and sterilization methods.
- Implement medical device risk management practices (ISO 14971).
- Utilize statistical tools (e.g., Minitab) for data analysis, TMV, and process capability studies.
