Manager, Manufacturing Engineering

Terumo•Davie, FL

3d•Onsite

About The Position

This 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. Responsible to provide direction of engineers, machine designers, and technicians.

Requirements

Thorough knowledge of statistical techniques, DMAIC/six-sigma certification preferred.
Demonstrated excellent analytical and problem solving skills.
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.
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.
Experience in development and validation of catheter and medical device manufacturing processes (e.g. extrusion, lamination, injection molding, tipping, shaping, bonding, etc).
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, 3 years of which shall have been supervisory in nature.
This position requires the ability to direct other to improve and validate manufacturing processes, and/or solve complex engineering problems.

Nice To Haves

DMAIC/six-sigma certification preferred.
Experience, training, or certifications in Lean manufacturing techniques a plus.
Expertise in Computer Aided Design, especially Solidworks, would be a plus.

Responsibilities

Associate 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 practicess, document/data control, change control practices.
Provide the engineering discipline 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.
Provide direction, leadership, and training to engineers, machine designers, and technicians; monitor work schedules and expenditures of project team.
Plan project improvements and troubleshooting of production equipment.
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.
This position could have a negative or positive result from the 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.
Performs other job related duties assigned.
May be responsible for projects which coordination with other department’s personnel for completion.