MDR - Sr Manufacturing Engineer
195 McDermott Road North Haven, CT 06473 US
SUMMARY OF POSITION: This position will be a member of the company'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 gain 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 CFN’s, 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
- Bachelor’s Degree Electrical, Mechanical, or Biomedical Engineering
- Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
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
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