Manufacturing Engineer II

CooperCompanies•North Tonawanda, NY

22h•Onsite

About The Position

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. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com . Work location: North Tonawanda, NY (on-site) Scope: The Manufacturing Engineer II is responsible for optimizing manufacturing processes and ensuring the production of high-quality medical devices. The Manufacturing Engineer II will directly contribute to continuous improvement initiatives and integration projects that reduce costs and increase the quality of CooperSurgical’s manufacturing processes. The Manufacturing Engineer II is expected to have strong partnerships with the production, quality, product engineering, and regulatory departments. Job Summary: The Manufacturing Engineer II at CooperSurgical is responsible for driving manufacturing excellence and optimizing production processes for our medical device and fertility products. The Manufacturing Engineer II plays a critical role in driving integration projects, implementing lean principles, improving process efficiency, and fostering a culture of continuous improvement.

Requirements

Bachelor’s degree in mechanical engineering, Industrial Engineering, or a related field.
2-5 years of experience in manufacturing engineering within the medical device or pharmaceutical industry.
Intermediate knowledge of medical device manufacturing processes.
Strong computer skills with the ability to use Excel, Word, PowerPoint, and Visio.
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.
Working knowledge of 21 CFR Parts 210, 211, and 820 within a combination product environment, with a solid understanding of FDA expectations
2-5 years of experience in manufacturing engineering within the medical device or pharmaceutical industry.
Intermediate knowledge of medical device manufacturing processes.

Nice To Haves

Experience in any of the following desired: Injection molding Electronics Automation
Advanced skills preferred.
Experience in any of the following desired: Electronics Automation Assembly

Responsibilities

Serve as the manufacturing transfer core-team member on integrations of new product acquisitions
Design and development of efficient manufacturing processes for medical device products, with a focus on quality, cost-effectiveness, and scalability.
Optimize existing manufacturing processes to improve efficiency, yield, and productivity while maintaining compliance with regulatory and quality standards, often using lean manufacturing techniques.
Conduct process validations, process capability studies, and root cause analyses to identify and resolve manufacturing issues, implementing corrective 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.
Ownership, review and management of Standard operating procedures, PFMEA and Control Plan process and all related documentation documents.
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.