Manufacturing Engineer III CooperSurgical - 3.4 Trumbull, CT Job Details Full-time 1 day ago Qualifications Statistics Industrial automation Performance improvement leadership Project engineering Content creation for technical audiences Defect resolution root cause analysis Technical documentation ISO standards Quality control statistical data analysis Design of manufacturing processes Statistical Process Control Six Sigma methodology implementation Engineering process optimization Visio Project management experience in manufacturing Factory operations documentation Minitab Manufacturing standard operating procedures Team development Technical solutions implementation Collaboration with product development teams Professional development support Production validation processes Medical device manufacturing facility experience Team management Cost analysis Task prioritization Project management experience in healthcare Compliance documentation Mentoring Full Job Description The Manufacturing Engineer III, concentrated on controls, automation, and electronics (ME3) at CooperSurgical will focus on solutioning complex manufacturing problems and implementing process improvements. The ME3 will apply their skills in automation and electronics via the implementation of new, and improvement of existing, automation systems, investigation of the root cause of various complex manufacturing problems and support daily operations through the support of the maintenance technician team. The ME3 may lead large projects that may have up to 2 supporting engineers 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 business unit of CooperCompanies (
Nasdaq:
COO) , we're driven by a unified purpose of helping people 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. Strong knowledge of medical device manufacturing processes. Experience in any of the following: Controls, Automation, and/or Electronics Strong computer skills with the ability to use Excel, Word, PowerPoint, and Visio. Advanced skills 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. 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. Design and development of efficient manufacturing processes and automation for medical device products, with a focus on quality, cost-effectiveness, and scalability. Optimize existing manufacturing processes via automation and the application of Lean Six Sigma concepts 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. Develop and lead 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. Provide mentorship and guidance to junior manufacturing engineers, fostering 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.