Manufacturing Engineer - Katalyst Healthcares & Life Sciences
North Haven, CT 06473
About the Job
Responsibilities:
- Develop, optimize, and validate manufacturing processes using IQ, OQ, PQ, and DOE methodologies.
- Implement statistical process control (SPC) to monitor and improve process performance.
- Conduct process capability studies and identify Critical to Quality (CTQ) parameters.
- Ensure compliance with ISO 13485, 21 CFR 820, FDA regulations, and GMP standards.
- Support Quality Management Systems (QMS) and contribute to pFMEA and risk management activities.
- Create and revise Standard Operating Procedures (SOPs) and User Requirements Specifications (URS).
- Coordinate Engineering Change Requests (ECR), Engineering Change Orders (ECO), and Engineering Change Notices (ECN).
- Identify root causes of manufacturing issues and implement effective solutions.
- Apply lean manufacturing principles to improve efficiency and reduce waste.
- Utilize tools such as Minitab and Agile methodologies for data analysis and project tracking.
- Ensure compliance with clean room standards and best practices for medical device production.
- Bachelor's degree in engineering (Mechanical, Industrial, Manufacturing, or related field).
- 3+ years of experience in manufacturing engineering, preferably in the medical device industry.
- Proficient in process validation (IQ, OQ, PQ) and design of experiments (DOE).
- Strong knowledge of ISO 13485, 21 CFR 820, and GMP regulations.
- Experience with SPC, pFMEA, QMS, and clean room operations.
- Proficiency in tools like Minitab, Agile software, and other statistical analysis platforms.
- Excellent problem-solving and project management skills.
- Medical Device.
- Process Validation.
- Team Leadership.
- SPC (Statistical Process Control).
- ISO 13485.
- IQ, OQ, PQ, DOE.
- Regulatory Compliance.
- pFMEA.
- SOP.
- URS.
- QMS.
- Clean Rooms.
- CTQ.
- FDA.
- GMP.
- Processes Engineering Changes (ECR, ECO, ECN).
- Problem Solving.
- Agile.
- Minitab.
- 21 CFR 820.
- Project Management.
- Project Planning.
Source : Katalyst Healthcares & Life Sciences