eeking a highly skilled and experienced Senior Manufacturing Engineer to join our dynamic team. The ideal candidate will play a critical role in optimizing our manufacturing processes, ensuring product quality, and driving continuous improvement initiatives. This position requires a strong background in medical device manufacturing, process engineering, and project management.
Key Responsibilities:
- Lead the development, implementation, and optimization of manufacturing processes for new and existing medical devices.
- Collaborate with cross-functional teams, including R&D, Quality, and Regulatory, to ensure seamless product development and transfer to manufacturing.
- Identify and implement process improvements to enhance efficiency, reduce costs, and maintain high-quality standards.
- Conduct root cause analysis and implement corrective actions to resolve manufacturing issues.
- Develop and maintain detailed process documentation, including work instructions, standard operating procedures (SOPs), and validation protocols.
- Oversee equipment selection, installation, and qualification to support manufacturing operations.
- Ensure compliance with FDA regulations, ISO standards, and other relevant industry guidelines.
- Mentor and provide technical guidance to junior engineers and manufacturing staff.
- Participate in continuous improvement initiatives, such as Lean Manufacturing and Six Sigma projects.
Qualifications:
- Bachelor's degree in Mechanical Engineering, Industrial Engineering, or a related field. A Master's degree is preferred.
- Minimum of 3-5 years of experience in manufacturing engineering, preferably in the medical device industry.
- Strong knowledge of FDA regulations, ISO 13485, and GMP requirements.
- Proven experience with process validation, equipment qualification, and root cause analysis.
- Proficiency in CAD software and manufacturing process simulation tools.
- Excellent problem-solving skills and attention to detail.
- Strong project management skills with the ability to manage multiple projects simultaneously.
- Effective communication and interpersonal skills to work collaboratively with cross-functional teams.
- Certification in Lean Manufacturing or Six Sigma is a plus.
