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CooperSurgical · 4 days ago
Molding/Extrusion Process Engineer II
Trumbull, CT
Full-time
Onsite
Mid Level
2+ years exp
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Hiring Manager
Katie A.
Insider Connection @CooperSurgical
Responsibilities
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.
Qualification
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Required
Bachelor’s degree in plastics engineering technology, mechanical engineering, Industrial Engineering, or a related field.
2-5 years of experience in manufacturing engineering within the medical device or pharmaceutical industry.
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.
Preferred
Injection molding certification preferred.
Benefits
Medical coverage
401(k)
Parental leave
Fertility benefits
Paid time off for vacation, personal, sick, and holidays
Other perks and benefits
Company
CooperSurgical
CooperSurgical provides a full portfolio of medical and surgical products. It is a sub-organization of The Cooper Companies.
1,001-5,000 employees
H1B Sponsorship
CooperSurgical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (7)
2022 (13)
2021 (6)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Kerry Blair
Chief Operating Officer
Lisa Fawcett
Executive Vice President, Strategy & Market Development
Recent News
2024-02-10
Business Wire India
2023-09-20
Company data provided by crunchbase
