Manufacturing Engineering Manager

Job Summary:

This Manager position is responsible for planning, directing and implementing projects to improve manufacturing processes of existing products or development of new products that directly affect safety, quality, and productivity with the end result of producing a better-quality product more efficiently. This position will have direct reports and will be responsible for associate oversite, guidance and leadership.

Job Details:

• The Manager is responsible to follow and direct the requirements of TMC Quality System related to engineering and process control systems; including but not limited to: process controls, calibration and maintenance practices, document/data control, change control practices.
• Provide knowledge and leadership required to plan and implement projects to develop,
• install, and qualify new processes for manufacturing new products or for improving existing processes to achieve business plan objectives.
• Provide engineering expertise in the design, fabrication, development, installation and qualification of equipment which may include feasibility studies and/or proper documentation for justification of project and training to ensure proper operation of the equipment
• Manage the workload and deployment of a team of associates to ensure support of the business by evaluating resource supply vs. demand and ensuring an appropriate organizational structure and skillset/experience mix is created.
• Plan project improvements and troubleshooting of production equipment
• Establish and promote a work environment that supports compliance Terumo's policie
• Identify cost reduction projects and financial analysis (justification of capital)
• Plan work schedules, expenditures, attend meetings, and prepare monthly reports are required
• This position has a wide-range impact on product quality, company profitability, and capacity due to implementation of projects, process changes, and capital expenditures.
• Participates in project performance team meetings on behalf of the job unit in order to provide ideas, methods, or processes for unit/company performance improvement.
• Responsible for projects which coordination with other department's personnel for completion, including guidance for direct reports within the project processes.
• Performs other job-related duties assigned.

Position Requirements:

Knowledge, Skills and Abilities (KSAs)

• Thorough knowledge of statistical techniques, 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. 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.

Background Experiences

• 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.