Manufacturing 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. 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: Trumbull, CT (on-site)

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 sustaining, continuous improvements, 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.

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 sustaining existing product portfolios, driving integration projects, implementing lean principles, and fostering a culture of continuous improvement.

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

• Ability to read and understand electrical schematics and 2D/3D drawings/specifications

• 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.

Experience:

• 3-7 years of experience in manufacturing engineering within the medical device or pharmaceutical industry.

• Experience with medical device regulation (ISO 13485) and good manufacturing practices (GMP).

• Experience in any of the following fields preferred:

• Electronics

• Automation

Education:

• Bachelor''s degree in mechanical engineering, electrical engineering, industrial engineering, or related field.

• Lean Six Sigma Certification Preferred

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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.

• Design and development of efficient manufacturing processes for medical device products, with a focus on quality, cost-effectiveness, and scalability.

• Creation and maintenance of various manufacturing systems including ERP, PLM, QMS, and CMMS.

• 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.

• Serve as the manufacturing transfer core-team member on integrations of new product acquisitions

• 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.

• Design and development of efficient manufacturing processes for medical device products, with a focus on quality, cost-effectiveness, and scalability.

• Creation and maintenance of various manufacturing systems including ERP, PLM, QMS, and CMMS.

• 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.

• Serve as the manufacturing transfer core-team member on integrations of new product acquisitions

• 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.