Validation Engineer
Job in
North Haven, New Haven County, Connecticut, 06473, USA
Listed on 2026-02-28
Listing for:
Intellectt Inc
Full Time
position Listed on 2026-02-28
Job specializations:
-
Engineering
Quality Engineering, Manufacturing Engineer, Process Engineer
Job Description & How to Apply Below
Responsibilities
- Oversee and optimize complex production processes for surgical devices, ensuring efficiency and quality standards.
- Serve as the primary technical expert for electro-mechanical equipment issues, diagnosing root causes and implementing corrective actions to reduce downtime.
- Lead development and execution of validation strategies (IQ/OQ/PQ) for new and existing equipment.
- Apply Lean principles to improve process stability and reduce waste.
- Conduct and lead non-conformance (NCMR) and Corrective and Preventive Action (CAPA) investigations.
- Support adaptation of machine/equipment design to production conditions.
- Bachelor’s degree in Electrical Engineering, Controls, Automation, Mechatronics, or related field.
- 10+ years of manufacturing engineering experience (or 8+ years with a Master’s degree).
- Expertise in medical device process validation (IQ/OQ/PQ) and statistical analysis using Minitab.
- Proven ability to troubleshoot automated systems including robotics, motion control, and machine vision.
- Strong statistical analysis skills: process capability, process control, DOE, and inspection design.
- In-depth understanding of Production Part Approval Process (PPAP) for component qualification.
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