Senior Manufacturing Engineer
4 weeks ago
This role requires a unique blend of technical expertise and leadership skills to drive manufacturing engineering activities and project management initiatives. As a Senior Manufacturing Engineer, you will apply advanced knowledge of engineering principles to solve complex problems related to product design and manufacturing processes. As a Project Manager, you will plan and execute multi-functional product improvement efforts, product transfer projects, and continuous improvement initiatives.
Key Responsibilities- Provide technical leadership to cross-functional project teams and ensure design requirements are met and comply with applicable standards.
- Coordinate technical resources to identify and resolve project issues, develop and manage plans to fix, test, and implement solutions.
- Ensure project risks are identified and addressed within the project plan, develop risk mitigation plans.
- 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, oversee validation project teams, prepare agendas, issue meeting minutes, and participate in development of quality plans.
- Write, review, and approve validations, Standard Operating Procedures, technical reports, and final reports for new products, processes, and equipment.
- Ensure all projects and processes follow FDA, Good Manufacturing Practices, Quality System Requirements, and ISO standards.
- Identify and implement opportunities for continuous improvement.
- Communicate project information to the project team and executive management.
- Bachelor's degree in engineering, advanced degree a plus.
- Eight years of previous manufacturing engineering experience preferred.
- Previous experience within a regulated medical device or pharmaceutical environment.
- Requires full and comprehensive knowledge of the complete product lifecycle, including all aspects of 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 is desirable.
- Product development experience, including three years in successful technical leadership, project coordination, or project management are required.
- 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 to suggest proper design improvements.
- Expertise in writing and performing validations in a regulated environment.
- Knowledge of statistical sampling and analysis.
- Understanding of FDA, Good Manufacturing Practices, ISO standards, and Occupational Safety and Health Administration regulations.
- Excellent written and verbal communication skills.
- Excellent equipment failures troubleshooting skills are required.
- Working knowledge of MS Office, knowledge of statistical software and large enterprise resource planning systems preferred.
- Excellent organizational and time management skills, attention to detail.
Approximately 20% international mobility required.
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