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Manufacturing Engineer III

CVI
Trumbull, USA
Full-time
Mid
Onsite
Discovered 3 weeks ago

Full Job Posting

Qualifications

  • 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.

Responsibilities

  • 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.

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