Manufacturing Engineer II- Industrial (LSS)
5 Days Old
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
Scope:
The Manufacturing Engineer II - Industrial (LSS) is responsible for optimizing industrial processes and ensuring the production of high-quality medical devices through implementation of Lean Six Sigma processes and concepts. The Manufacturing Engineer II - Industrial (LSS) will directly contribute to process improvement initiatives and integration projects that reduce costs and increase the quality of CooperSurgical's industrial processes. Manufacturing Engineer II - Industrial (LSS) is expected to have strong partnerships with the production, quality, product engineering, and regulatory departments.
Job Summary:
The Manufacturing Engineer II - Industrial (LSS) at CooperSurgical is responsible for applying Lean Six Sigma concepts to drive manufacturing excellence, as well as identifying, scoping, and evaluating process improvements for our medical device and fertility products. Manufacturing Engineer II - Industrial (LSS) plays a critical role in driving integration projects, implementing Lean Six Sigma principles, enhancing operational efficiency and product quality, and fostering a culture of process improvement initiatives.
Responsibilities
- Develop and implement Lean Six Sigma concepts, procedures, and standards at the manufacturing site
- Serve as a manufacturing transfer core-team member on integrations and new product acquisitions, focused on facilitation and implementation of Lean Six Sigma concepts
- Design and development of efficient industrial processes for medical device products, with a focus on quality, cost reduction and quality improvement, and scalability.
- Optimize existing industrial processes to improve efficiency, yield, and productivity while maintaining compliance with regulatory and quality standards, often using Lean Six Sigma methodologies.
- Conduct process evaluations and validations, process capability studies, and root cause and statistical analyses to identify and resolve manufacturing issues, implementing corrective and preventive 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.
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:
- Travel may be required to attend meetings or visit manufacturing sites. Approx. 10-20% travel is expected.
Qualifications
- Bachelor's degree in industrial engineering, Manufacturing Engineering, or a related field.
- Intermediate knowledge of medical device industrial processes
- Strong computer skills with the ability to use Excel, Word, PowerPoint, and Visio. Advanced skills preferred.
- Subject Matter Expertise in Lean Six Sigma concepts and tools for process optimization, 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.
- Ability to work in uncomfortable positions, when required. For example, when repairing various manufacturing equipment.
Experience:
- 5-10 years of experience in industrial engineering, focused on Lean Six Sigma initiatives, within the medical device or pharmaceutical industry.
Education:
- Bachelor's degree in industrial engineering, Manufacturing Engineering, or a related field
- Lean Six Sigma:
- Minimum: Green Belt
- Preferred: Black Belt
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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.
- Location:
- Trumbull