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MDR - Sr Manufacturing Engineer

North Haven, CT 06473

Posted: 11/21/2023 Employment Type: Contract Job Category: Engineering Job Number: 592095 Is job remote?: No Country: United States

Job Description


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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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