Manufacturing Engineer
Katalyst HealthCares & Life Sciences
- Indianapolis, IN
- Permanent
- Full-time
- We are urgently hiring three Manufacturing Engineers with strong experience in medical device manufacturing and remediation.
- These roles will focus on remediation activities, process optimization, and ensuring compliance with regulatory standards.
- The ideal candidates will bring expertise in validation, CAPA, and risk management, while working cross-functionally to resolve compliance gaps and strengthen manufacturing operations.
- Remediation Initiatives.
- Lead remediation projects by identifying and addressing root causes of product or process deficiencies.
- Develop and implement Corrective and Preventive Actions (CAPAs) and remediation action plans.
- Conduct gap analyses of processes, documentation, and equipment to ensure compliance.
- Manufacturing Process Engineering.
- Design, implement, and optimize manufacturing processes to improve efficiency, quality, and compliance.
- Apply Design for Manufacturability (DFM) principles to reduce risks and streamline production.
- Troubleshoot and resolve production issues with robust, sustainable solutions.
- Quality & Validation.
- Support process and product validation activities, including IQ/OQ/PQ and test method validation.
- Perform and document risk assessments (FMEA, PFMEA).
- Ensure remediation actions are verified and documented in line with QMS and regulatory standards.