What are the responsibilities and job description for the Sr Packaging Engineer position at Skysoft?
Job Title: Sr Packaging Engineer
Location: North Haven, CT
Work Arrangement: Onsite
Experience: 7 years
Visa: H1B transfer to SkySoft, GC, USC
About the Opportunity
Medtronic is seeking a Senior Packaging Engineer to support medical device packaging operations, process development, equipment qualification, and validation.
Key Responsibilities
Develop and improve packaging processes.
Perform IQ/OQ/PQ and packaging validation.
Troubleshoot packaging equipment and manufacturing issues.
Conduct root cause analysis and implement CAPA solutions.
Maintain technical documentation and ensure FDA compliance.
Drive continuous improvement using Lean and Six Sigma.
Collaborate with Quality, Regulatory, Manufacturing, and Engineering teams.
Required Qualifications
Bachelor's degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or a related field.
7 years of Packaging Engineering experience.
Experience with packaging validation, IQ/OQ/PQ, and equipment qualification.
Knowledge of CAPA, root cause analysis, and quality systems.
Experience in regulated manufacturing environments.
Ability to work onsite in North Haven, CT.
Preferred Qualifications
Medical device, pharmaceutical, or healthcare packaging experience.
FDA-regulated manufacturing experience.
Lean Manufacturing or Six Sigma knowledge.
Packaging equipment troubleshooting and process improvement experience.
Must-Have Skills
1. 7 years of Packaging Engineering experience.
2. Packaging process development and improvement.
3. IQ/OQ/PQ and packaging validation.
4. Medical device, pharmaceutical, or regulated manufacturing experience.
5. CAPA and root cause analysis.
6. FDA compliance and quality systems.
7. Packaging equipment qualification.
Required Qualifications
Bachelor's degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or a related field.
7 years of Packaging Engineering experience.
Experience with packaging validation, IQ/OQ/PQ, and equipment qualification.
Knowledge of CAPA, root cause analysis, and quality systems.
Experience in regulated manufacturing environments.
Ability to work onsite in North Haven, CT.
Salary : $40 - $43