Molding/Extrusion Process Engineer II

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

• Executes basic engineering assignments independently such as ECNs, NPEs, LCNs, etc.

• Process Optimization: Continuously evaluate and improve molding/extrusion and downstream processes to enhance efficiency, productivity, reduce cycle times, and minimize waste, while maintaining compliance with regulatory and quality standards.

• Executes product transfers and acquisitions, managing the project throughout the PTR/PAR processs.

• Oversee the design, fabrication, and maintenance of molds and tooling used in the molding process to ensure optimal performance.

• Executes product integrations from R&D.

• Investigates complex manufacturing problems in the area of molding and extrusion

• Works cooperatively with Technical Operations, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing on complex projects to ensure project success.

• Executes validations of complex processes of manufacturing lines.

• Prepares complex reports and communicates results to the technical community.

• Analyzes, summarizes and provide conclusions from complex test results.

• Partners with the assigned Value Stream Team to ensure performance needs are met or exceeded by ensuring enough capacity, minimum scrap variances, and labor efficiency when processes are involved.

• Ensures that manufacturing validations, processes, and procedures comply with FDA, OSHA, ISO, and corporate regulations, policies and procedures.

• Designs and coordinates complex engineering tests and experiments.

• Define and execute improvement programs such as cost, quality, or capacity.

• Work with technical operations to modify part designs to improve manufacturability.

• Maintain a continuous improvement mindset and work with management to obtain buy in for technical improvement programs.

• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy.

• Perform other duties as directed by management.

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 plastics engineering technology, mechanical engineering, Industrial Engineering, or a related field.

OR

• 2-5 years of experience in manufacturing engineering within the medical device or pharmaceutical industry.

• Injection molding certification preferred.

• Prior experience with and a strong working knowledge of molding/extrusion processes of various materials including both thermoplastics and silicone.

• In-depth knowledge of project management

• Strong computer skills with the ability to use Excel, Word, PowerPoint, and Visio. Advanced skills preferred.

• Knowledge of CAD software for tooling design 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.

• Thorough understanding of quality and regulatory requirements, such as ISO 13485, FDA QSR, EU MDR and GMP.

• 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.

• Prolonged standing on the manufacturing floor is common.

• Ability to work in uncomfortable positions, when required. For example, when performing maintenance activities.

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. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

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.