Role: Medical Device Validation Engineer
Location: Salt lake City, UT (Onsite)
Job Description:
Key Responsibilities
- Prior experience mandatory in Medical Devices domain.
- Plan, lead, and coordinate project execution and validation activities in alignment with ISO 13485 and ISO 14971.
- Support validation planning and execution of IQ, OQ, and PQ activities.
- Manage validation activities for equipment, process, and product transfers.
- Author and review validation documentation.
- Collaborate with cross-functional teams to ensure successful project execution.
- Coordinate with customers, manufacturing plants, and offshore teams to ensure project continuity and on-time delivery.
- Experience contributing as a Project Manager (PM) or Project Lead (PL) will be an added advantage.
Required Skills & Expertise
- Medical Devices Domain Experience
- ISO 13485
- ISO 14971
- IQ / OQ / PQ Validation
- Equipment Validation
- Process Validation
- Product Transfer Validation
- Validation Documentation
- Cross-Functional Collaboration
- Project Execution & Coordination
- Regulatory Affairs
- R&D Engineering
- PM / PL Experience (Preferred)
Ā
Sagar Bharadwaj
Sr. Technical Recruiter
6655 Deseo Dr ā¢ Suite 104 ā¢ Irving, TX ā¢ 75039
