Senior Manufacturing Engineer
4 weeks ago
Job Summary
This role requires a combination of technical leadership and project management skills to support a complex range of manufacturing engineering activities. 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. As a Project Manager, one will plan and manage 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 the root cause of project issues and develop and manage a plan to fix, test, and implement an appropriate solution.
- Ensure project risks are identified and addressed within the project plan and develop risk mitigation plans.
- Work as a lead project team member to complete all activities needed to conclude projects per plans.
- Develop and implement process controls for product transfer to manufacturing or to new manufacturing sites.
- Conduct regular project team status meetings and reviews and oversee validation project teams.
- Write, review, and approve validations and technical reports for new products, processes, and equipment.
- Ensure all projects and processes follow FDA, GMP, QSR, and ISO standards.
- Identify and implement opportunities for continuous improvement.
Requirements
- Bachelor's degree in engineering; advanced degree a plus.
- Eight years 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.
- Experience in the development and release of at least one successful product launch of a medical instrumentation product is desirable.
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 to suggest proper design improvements.
- Expertise in writing and performing validations in a regulated environment.
- Knowledge of statistical sampling and analysis.
- Understanding of FDA, GMP, ISO standards, and OSHA regulations.
- Excellent written and verbal communication skills.
- Excellent equipment failures troubleshooting skills.
- Working knowledge of MS Office and statistical software.
Travel Requirements
Approximately 20% international mobility required.
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