Senior Manufacturing Engineer in the Medical Devices industry
Job Overview
We are hiring a Senior Manufacturing Engineer in the Medical Devices industry
We are looking for a highly skilled professional to drive the development, implementation, and continuous improvement of manufacturing processes. This role plays a critical part in ensuring compliance with product specifications, quality standards, and FDA regulations.
Key Responsibilities
- Perform installation and validation activities for production lines, including equipment, process, product, and test method validations, in compliance with regulations.
- Design and implement manufacturing processes, procedures, and production layouts for assemblies, equipment, and material handling.
- Support product improvements in areas such as risk management, test method validation, process validation, process control, supplier qualification, complaint investigations, CAPA, and process improvement.
- Execute and manage documentation in PLM systems (e.g., update DHRs, BOMs, work instructions, and create part numbers).
- Investigate and resolve production issues using structured problem-solving methods.
- Lead or support cross-functional manufacturing projects and initiatives.
- Provide guidance to engineering teams on design concepts and specifications to optimize manufacturing efficiency.
- Ensure compliance of processes and procedures with all applicable regulatory requirements.
We are seeking a results-driven engineer with a strong technical background and proven ability to lead complex manufacturing initiatives. If this opportunity aligns with your expertise, we encourage you to apply.
Requirements
Qualifications
- 5+ years of experience as a Manufacturing Engineer in the Medical Devices industry.
- Fluency in English and Spanish (minimum B2).
- Experience leading validation plans for medical products and processes.
- Hands-on experience in product and process transfers.
- Strong background in root cause analysis and problem-solving methodologies.
- Project Management experience is considered a plus.
- Strong documentation and communication skills.