Manager, Manufacturing Engineering

Terumo Cardiovascular Group; Town of Florida (NY); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Annual bonus

Paid vacation

Health insurance

401(k) with matching

Job summary

Terumo Cardiovascular Group in Sunrise, FL, seeks an experienced manufacturing engineer to plan, direct and implement projects that enhance production efficiency and product quality. You will lead engineers, machine designers, and technicians, drive new process development, and ensure GMP/FDA compliant validations across cross‑functional teams.

Required is a BS in engineering with 8+ years in manufacturing and at least 3 years in a supervisory role.

Qualifications

• BS in Mechanical, Chemical, Biomedical engineering or related field; MS/PhD preferred.
• Minimum 8 years in manufacturing with 3+ years supervisory experience.
• Ability to lead and develop engineering teams to improve and validate processes.

Responsibilities

• Plan, direct and implement projects to improve manufacturing processes.
• Lead engineers, machine designers, and technicians; manage schedules and budgets.
• Develop, install and qualify new processes for manufacturing new or improved products.
• Ensure GMP/FDA compliance and execute process validations.

Skills

DMAIC Six Sigma

Analytical skills

Lean manufacturing

Cross-functional teamwork

Problem solving

Education

BS in Mechanical Engineering

MS/PhD preferred

Tools

SolidWorks

CAD

Job description

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At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy.

The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.

Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associate’s role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide.

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!

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.

1. 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.
2. 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
3. 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
4. Provide direction, leadership, and training to engineers, machine designers, and technicians; monitor work schedules and expenditures of project team
5. Plan project improvements and troubleshooting of production equipment
6. Identify cost reduction projects and financial analysis (justification of capital)
7. Plan work schedules, expenditures, attend meetings, and prepare monthly reports are required
8. This position has a wide‑range impact on product quality, company profitability, and capacity.
9. This position could have a negative or positive result from the implementation of projects, process changes, and capital expenditures.
10. 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.
11. Performs other job related duties assigned.
12. May be responsible for projects which coordination with other departmentâÂÂs 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 manufacturing environment for implementing major manufacturing and automation projects, 3years 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.

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.

Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long‑term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program.

Nearest Major Market: Fort Lauderdale
Nearest Secondary Market: Miami