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Senior Process Improvement Engineer
2 months ago
POSITION OVERVIEW
The Senior Process Improvement Engineer will play a crucial role in enhancing manufacturing methodologies and driving operational excellence within the medical device sector.
Key Responsibilities:
1. Assess, design, validate, and execute manufacturing workflows and enhancements tailored for medical devices and regulated sectors.
2. Utilize problem-solving techniques, conduct root cause analyses, and leverage experience with Corrective and Preventive Actions (CAPA).
3. Apply principles of lean manufacturing and Six Sigma methodologies to optimize processes.
Qualifications:
- A Bachelor of Science Degree in Mechanical Engineering, Packaging Science, or a related field is mandatory.
- A minimum of 5 years of experience in the medical device or pharmaceutical manufacturing environment, specifically in Manufacturing Engineering, Packaging, or Quality Engineering.
Demonstrated expertise and practical knowledge in manufacturing engineering, process development, and packaging engineering, typically acquired through advanced education and relevant experience.
- Familiarity with Lean manufacturing and Six Sigma practices is essential.
- Understanding of ISO 11607 part 2, ASTM, and ISTA packaging testing methods is advantageous.
Work Environment:
This position requires on-site presence for 4-5 days a week.
Product Focus:
The engineer will be involved in supporting the development and enhancement of cardiac ablation solutions, including cardiac mapping and navigation systems, as well as catheter-based cardiac ablation technologies.
Core Activities:
- Lead and assist in various process improvement initiatives and remediation tasks.
- Design and procure fixtures, oversee installation and validation processes.
- Conduct process mapping, development, time studies, and layout planning.
- Set up labeling systems, manage system updates, and maintain documentation.
- Execute process validation (IQ/OQ/PQ) and author/update engineering protocols and reports.
- Manage documentation updates in Product Lifecycle Management (PLM) systems, including BOM, SOPs, visual aids, drawings, and work instructions.
- Facilitate Root Cause Analysis, Measurement System Analysis, and Gemba walks, and update PFMEA and control plans.
- Support Non-Conforming Material Reports (NCMRs), CAPAs, and audit findings.
- Provide weekly updates and administrative support as required.
- Conduct testing and provide manufacturing and engineering support as necessary.
Minimum Requirements:
- Bachelor of Science Degree in Mechanical Engineering, Packaging Science, or a similar discipline.
- At least 5 years of experience in the medical device or pharmaceutical industry in roles related to Manufacturing Engineering, Packaging, or Quality Engineering.
Practical knowledge and demonstrated competence in manufacturing engineering, process development, and packaging engineering are essential, typically gained through advanced education combined with relevant experience.
- Knowledge and working experience of Lean manufacturing and Six Sigma practices are required.
- A general understanding of ISO 11607 part 2, ASTM, and ISTA package test methods is preferred.
