- CAD
- Windows
- Continuous improvement
- Packaging
- Computer skills
About the Job:
This main purpose of this Role is to provide support to a High Volume/High Mix Manufacturing Value Stream. You will own, plan and execute activities ranging from Sustaining, Change Control, New Product Introduction, issue resolution through effective Root Cause and Corrective Action and Continuous Improvement. By careful monitoring and analysis of process metrics and data, you will ensure that Epredia can deliver those lifesaving products that our Patients need.
The Role reports to the Sr Manufacturing Engineering Manager and is peer to a dynamic & diverse Team of Engineers. Come join us so you can be part of a unique manufacturing processes and learn to master the skills needed in this kind of environment.
In this role you will:
Design and execute Validation and/or Qualification exercises
Support investigations in product quality problems, determines root cause, gather and analyze data and implement corrective action to reduce or eliminate cause.
Support continuous improvement initiatives per CI tools used in Business Operating System.
Provide support and own tasks as needed for New Product Introduction, Change Control and Sustaining Projects.
Ensure processes and equipment fully comply with Safety, QMS and CGMP requirements.
Conduct capacity studies, enhance system reliability, and identify/implement productivity improvements including new technologies.
Support Capital Expense planning, documentation and execution.
Develop/maintain strategic technical improvement plans for systems.
Serve as a technical liaison for all levels of the company including production/maintenance employees, plant technical and management resources, marketing, R&D organizations, customers and other plants.
Design and fabrication of jigs, tools, fixtures, gages, and special equipment.
Perform process capability studies to increase control and lower total quality costs.
Actively participate in definition of quality requirements, justification of acceptance limits and sampling plans to assure compliance with requirements.
Identify areas for improvement. Recommend solutions to identified problems. Implement approved changes using sound engineering principles and fully document requirements on a timely basis.
Work closely with Manufacturing Operations to Identify and resolve production and quality system deficiencies
Owns and executes completion of CAPA actions
Assist in the development of a safe working environment using occupational safety and health standards, including ergonomic principles.
Additional duties as assigned.
Skills/Qualifications you need for the role:
Be able to lift 25 pounds.
Must be capable of working for extended periods in a manufacturing environment.
Work standing on hard surfaces, ladders, under and around equipment.
Be a self-starter, work without supervision, able to set up work plan and material requirement, coordinate with colleagues, contractor and clients to carry out the work assigned.
Bachelor’s degree preferred in a relevant Engineering Discipline. (Mechanical, Biomedical, Chemical or Electrical preferred).
5-10 years’ experience in process and/or packaging engineering, process/system development, product development, quality engineering, or manufacturing.
Advanced computer skills, Windows Suite, CAD, Label design.
Advanced written and verbal communication.
Proficient in Process Validation principles and methodologies.
Proficient in use of statistical tools in a regulated manufacturing environment.
Proven track record of Project Management.
Proven track record of driving Continuous improvement.
Preferred experience in glass substrates, screen printing, and medical device manufacturing.
Preferred experience with automated and semiautomated manufacturing equipment.
