Manufacturing Engineer II
Trumbull, CT - USA
Job Summary
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 CooperSurgicals industrial processes. Manufacturing Engineer II Industrial (LSS) is expected to have strong partnerships with the production quality product engineering and regulatory departments.
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.
Qualifications
Bachelors 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.
Required Experience:
IC
About Company
Live Brightly. Our daily and monthly soft contact lenses are designed with your health and comfort in mind. For every eye, every person, and every day.