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Manager, Manufacturing Engineering

2 months ago

Elkton, United States Terumo Cardiovascular Group Full time

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come. At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients. Join us and help shape wherever we go next Advancing healthcare with heart 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. 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 practices, 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. Job Responsibilities (continued)

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

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. Experience in development and validation of catheter and medical device manufacturing processes (e.g. extrusion, lamination, injection molding, tipping, shaping, bonding, etc) Qualifications/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 a 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 others to improve and validate manufacturing processes, and/or solve complex engineering problems. It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.

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