Manufacturing Engineering Manager
2 days ago
This leadership position is responsible for planning, directing, and implementing projects to enhance manufacturing processes for existing products or the development of new products that directly impact safety, quality, and productivity, resulting in the production of a better-quality product more efficiently.
Key Responsibilities- Direct and oversee the requirements of Terumo's Quality System related to engineering and process control systems, including process controls, calibration, and maintenance practices, document/data control, and change control practices.
- Provide knowledge and leadership to plan and implement projects to develop, install, and qualify new processes for manufacturing new products or improving existing processes to achieve business objectives.
- Offer engineering expertise in the design, fabrication, development, installation, and qualification of equipment, including feasibility studies and proper documentation for project justification and training to ensure proper equipment operation.
- Manage the workload and deployment of a team of associates to ensure business support by evaluating resource supply vs. demand and ensuring an appropriate organizational structure and skillset/experience mix.
- Plan project improvements and troubleshooting of production equipment.
- Establish and promote a work environment that supports compliance with Terumo's policies.
- Identify cost reduction projects and financial analysis (justification of capital).
- Plan work schedules, expenditures, attend meetings, and prepare monthly reports.
- Thorough knowledge of statistical techniques and DMAIC/six-sigma certification preferred.
- Demonstrated excellent analytical and problem-solving skills.
- Experience, training, or certifications in Lean manufacturing techniques a plus.
- Experience required in experimental design and analysis for process development, characterization, and optimization.
- Knowledge of GMP/FDA regulations and thorough knowledge of FDA process validations, including development of protocols and execution of protocols.
- Experience in leading or participating in cross-functional teams from concept to launch of new medical devices.
- Expertise in Computer Aided Design, especially Solidworks, would be a plus.
- Excellent communication skills both verbal and written.
- Requires strong communications skills to understand and explain complex engineering problems to non-engineering personnel.
- Thorough knowledge of equipment and tools in laboratory testing and inspection systems.
- BS in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Polymer Science, Materials Science, or related field, Advanced Degree (MS/PhD) preferred.
- Minimum 8 years' experience in manufacturing environment for implementing major manufacturing and automation projects.
- Minimum of 3 years of supervisory experience.
- Experience in development and validation of catheter and medical device manufacturing processes (e.g., extrusion, lamination, injection molding, tipping, shaping, bonding, etc.) is a plus.
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