Manufacturing Engineer II

CooperSurgical; Trumbull (CT); Presencial; USD 81.000 - 108.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Great compensation package

Medical coverage

401(k)

Parental leave

Fertility benefits

Paid time off for vacation

Paid time off for personal

Paid time off for sick

Paid time off for holidays

Multiple other perks and benefits

Descripción de la vacante

CooperSurgical is seeking a Manufacturing Engineer II – Industrial (LSS) to drive Lean Six Sigma based improvements across manufacturing. You will partner with production, quality, and regulatory teams to optimize processes, reduce costs, and ensure high-quality medical devices.

Responsibilities include leading transfer teams, designing efficient processes, validating capabilities, and maintaining robust process controls documentation.

Formación

• Lean Six Sigma concepts and tools applied to manufacturing.
• Strong problem-solving in cross-functional teams.
• Experience with regulatory standards (ISO 13485, FDA QSR).

Responsabilidades

• Develop and implement Lean Six Sigma concepts at the site.
• Lead manufacturing transfer on integrations and new products.
• Design efficient processes for medical devices emphasizing quality and cost.
• Optimize processes to improve efficiency, yield and productivity while complying with standards.
• Perform process evaluations, capability studies, and RCA.
• Contribute to project plans with risk assessments and regulatory strategies.
• Collaborate with R&D for manufacturability and process validation.
• Maintain manufacturing documentation including work instructions and SOPs.
• Support maintenance to resolve downtime on the floor.

Conocimientos

Lean Six Sigma

Process optimization

Statistical analysis

Minitab

Project management

Cross-functional teamwork

Regulatory knowledge

Communication skills

Educación

Bachelor's degree in Industrial Engineering or related field

Herramientas

Excel

Visio

Word

PowerPoint

Descripción del empleo

Job Description

The Manufacturing Engineer II – Industrial (LSS) is responsible for optimizing industrial processes and ensuring the production of high-quality medical devices through implementation of Lean Six Sigma processes and concepts. The Manufacturing Engineer II – Industrial (LSS) will directly contribute to process improvement initiatives and integration projects that reduce costs and increase the quality of CooperSurgical’s industrial processes. Manufacturing Engineer II – Industrial (LSS) is expected to have strong partnerships with the production, quality, product engineering, and regulatory departments.

Responsibilities

• Develop and implement Lean Six Sigma concepts, procedures, and standards at the manufacturing site
• Serve as a manufacturing transfer core-team member on integrations and new product acquisitions, focused on facilitation and implementation of Lean Six Sigma concepts
• Design and development of efficient industrial processes for medical device products, with a focus on quality, cost reduction and quality improvement, and scalability.
• Optimize existing industrial processes to improve efficiency, yield, and productivity while maintaining compliance with regulatory and quality standards, often using Lean Six Sigma methodologies.
• Conduct process evaluations and validations, process capability studies, and root cause and statistical analyses to identify and resolve manufacturing issues, implementing corrective and preventive actions as needed.
• Assist in the development of project plans and proposals that include elements such as Gantt charts, cost-benefit analysis, risk assessments, and regulatory strategies.
• Collaborate with R&D teams to ensure new products are designed for manufacturability, considering assembly methods, equipment selection, and process validation requirements.
• Contribute to the fostering of a culture of knowledge sharing and professional development.
• Develop and maintain manufacturing documentation, including work instructions, standard operating procedures, and process control plans, ensuring compliance with regulatory requirements.
• Support the manufacturing floor via partnering with maintenance engineers and technicians to resolve day-to-day downtime.

Qualifications

• Bachelor’s degree in industrial engineering, Manufacturing Engineering, or a related field.
• Intermediate knowledge of medical device industrial processes
• Strong computer skills with the ability to use Excel, Word, PowerPoint, and Visio. Advanced skills preferred .
• Subject Matter Expertise in Lean Six Sigma concepts and tools for process optimization, statistical analysis tools (e.g., Minitab), and root cause analysis.
• Excellent problem-solving skills and the ability to work effectively in a cross-functional team environment.
• Knowledge of quality and regulatory requirements, such as ISO 13485, FDA QSR, EU MDR and GMP.
• Strong project management skills, with the ability to prioritize tasks and manage multiple projects simultaneously.
• Excellent communication skills, both verbal and written, with the ability to convey complex technical information to diverse audiences.

Our Benefits

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan.

As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits.

• Great compensation package
• Medical coverage
• 401(k)
• Parental leave
• Fertility benefits
• Paid time off for vacation
• Paid time off for personal
• Paid time off for sick
• Paid time off for holidays
• Multiple other perks and benefits

Pay transparency statement (CA, CO, CT, HI, IL, MD, MN, NJ, NY, VT, WA, or Remote):

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $80,973 - $107,964. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.