Nice to Have:
Business Process Improvement
Experience in Agile PLM software
Experience in development and review of Bill of Materials
Experience in Electrical Engineering
Experience in the development of labeling for the medical device industry preferred.
Experience working in a fast paced Manufacturing environment Validation Experience (IQ, OQ, TMV, PQ) CAPA (Corrective Action / Preventive Action) Experience Familiarity with Minitab Statistical Software Six Sigma Training
JOB DESCRIPTION
Spotlight Call: Thursday Nov 9th 2:30 PM Central, 3:30 PM Eastern
Dial:
+*** US (Minnesota)
+*** US (San Jose)
Meeting ID:
***0
Passcode:
760856
SUMMARY OF POSITION: This position will be a member of ***s Surgical Robotics Advanced Manufacturing Engineering team working to support the development of packaging and labeling compliance and BOM structures within our Agile system. The position will assist in structuring a process for implementation of label changes within operations. The position will work closely with the following team graphics, quality, operations, and regulatory. This is an excellent opportunity to Product cross-functional experience developing activities at the intersection of robotics and medical devices. Examples of responsibilities are listed below.
Track the completion of labeling changes within out change development process
Draft/submit Brand Architecture documentation, create new versioned CFNs, and partner with the graphics team for label approval
Prepare validation protocols and reports to support packaging changes.
Perform packaging validation testing to support changes.
Assist in artwork creation and revisions for product packaging.
Ensure on time delivery to Project Engineering and R&D schedules and plans.
Prepare monthly progress reports on projects.
Provide work direction to lab technicians as required.
Conduct review meetings with multiple facilities regarding packaging and labeling issues.
Packaging materials, labeling, and IFU processes
Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & Medical Device Good Manufacturing Practices
Managed or lead root cause analysis / CAPA
Experience in 6 Sigma and Lean Principals
Project Management experience
Experience with Minitab or other statistical software
Schedule project meetings, document minutes and key decisions, track action items
Provide meeting planning assistance to other team members for their meetings
Manage special projects as needed
Must Have: Minimum Requirements
Bachelors Degree Electrical, Mechanical, or Biomedical Engineering
Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience •
Last updated on Nov 8, 2023