Manufacturing Engineer III

About CooperSurgical:

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com.

Work location: Trumbull, CT

Job Summary:

The Manufacturing Engineer III at CooperSurgical is responsible for driving manufacturing excellence and optimizing production processes for our medical device and fertility products. The Manufacturing Engineer III plays a critical role in implementing lean principles, improving process efficiency, and fostering a culture of continuous improvement.

Essential Functions & Accountabilities:

1. Design and development of efficient manufacturing processes for medical device products, with a focus on quality, cost-effectiveness, and scalability.
2. Optimize existing manufacturing processes to improve efficiency, yield, and productivity while maintaining compliance with regulatory and quality standards, often using lean manufacturing techniques.
3. Conduct process validations, process capability studies, and root cause analyses to identify and resolve manufacturing issues, implementing corrective actions as needed.
4. Develop project plans and proposals that include elements such as Gantt charts, cost-benefit analysis, risk assessments, and regulatory strategies.
5. Collaborate with R&D teams to ensure new products are designed for manufacturability, considering assembly methods, equipment selection, and process validation requirements.
6. Provide mentorship and guidance to junior manufacturing engineers, fostering a culture of knowledge sharing and professional development.
7. Develop and maintain manufacturing documentation, including work instructions, standard operating procedures, and process control plans, ensuring compliance with regulatory requirements.
8. Support the manufacturing floor via partnering with maintenance engineers and technicians to resolve day-to-day downtime.

Cooper’s management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.

Travel: 

• Occasional travel may be required to attend meetings, conferences, or visit manufacturing sites. Approximately 10-20% travel is expected.

 

• Bachelor’s degree in mechanical engineering, Industrial Engineering, or a related field. Master's degree preferred.

OR

• 5-10 years of experience in manufacturing engineering within the medical device or pharmaceutical industry.
• Strong knowledge of medical device manufacturing processes. Experience in any of the following desired: 
  • Injection molding
  • Electronics  
  • Automation
• Strong computer skills with the ability to use Excel, Word, PowerPoint, and Visio. Advanced skills preferred. 
• Proficiency in Lean Six Sigma concepts, 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.

Work Environment:

• Occasional lifting of up to 35 kilograms may be required.
• Prolonged sitting in front of a computer is common.
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