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Senior Manufacturing Engineer
1 month ago
Job Summary
This role requires a combination of technical expertise and leadership skills to support complex manufacturing engineering activities, including product design and manufacturing processes. As a Senior Manufacturing Engineer, one will apply advanced knowledge of engineering principles and analyses to solve multifaceted issues related to product design and manufacturing processes.
Key Responsibilities
- Provide technical leadership to cross-functional project teams to ensure design requirements are met and comply with applicable standards.
- Coordinate technical resources to identify the root cause of project issues and develop plans to fix, test, and implement solutions.
- Ensure project risks are identified and addressed within the project plan, developing risk mitigation plans as needed.
- Work as a lead project team member to complete all activities needed to conclude projects per plans, responsible for project planning and scheduling.
- Develop and implement process controls for product transfer to manufacturing or new manufacturing sites.
- Conduct regular project team status meetings and reviews, overseeing validation project teams and preparing agendas and meeting minutes.
- Write, review, and approve validations, Standard Operating Procedures, and technical reports for new products, processes, and equipment.
- Ensure all projects and processes follow FDA, GMP, QSR, and ISO- standards, identifying and implementing opportunities for continuous improvement.
Requirements
- Bachelor's degree in engineering, advanced degree a plus.
- Eight years of previous manufacturing engineering experience, preferably in a regulated medical device or pharmaceutical environment.
- Full and comprehensive knowledge of the product lifecycle, including product development from conception to manufacturing introduction.
- Experience in the development and release of at least one successful product launch of a medical instrumentation product, with three years of successful technical leadership, project coordination, or project management experience.
Skills and Capabilities
- Six sigma green belt or black belt methodology a plus.
- Extensive knowledge and experience in process and product manufacturing.
- Experience in creating and understanding engineering drawings, schematics, specifications, tolerancing, and bills of materials.
- In-depth experience with automation development and expertise in writing and performing validations in a regulated environment.
- Knowledge of statistical sampling and analysis, as well as understanding of FDA, GMP, ISO standards, and OSHA regulations.
- Excellent written and verbal communication skills, with the ability to troubleshoot equipment failures and work knowledge of MS Office and statistical software.
Travel Requirements
Approximately 20% international mobility required.
