Senior Packaging Engineer – Medical Device Manufacturing

Intellectt Inc; North Haven (CT); On-site; USD 105,000 - 135,000; Full time

Job summary

Intellectt Inc. is seeking an experienced Senior Packaging Engineer to lead packaging process development, equipment qualification, and validation efforts in a regulated medical device environment.

You will ensure FDA and quality system compliance, collaborate across Manufacturing, Quality, Regulatory, and Engineering teams, and drive continuous improvement through Lean and Six Sigma methodologies. This role requires a Bachelor’s in a related field and 7+ years of experience.

Qualifications

• Bachelor’s degree in a relevant engineering discipline is required.
• 7+ years of Packaging Engineering experience, or an advanced degree with relevant experience.
• Knowledge of packaging validation, manufacturing processes, quality systems, and regulatory requirements.
• Strong problem-solving, project leadership, and technical communication skills.
• Ability to collaborate effectively with cross-functional teams.

Responsibilities

• Lead packaging process development and improvement activities.
• Perform packaging equipment qualification and process validation, including IQ/OQ/PQ.
• Collaborate with cross-functional teams to resolve manufacturing and production issues.
• Conduct root cause investigations and develop corrective and preventive actions (CAPA).
• Maintain technical documentation and support packaging validation activities.
• Ensure compliance with FDA regulations and applicable quality system requirements.
• Drive operational excellence through Lean Manufacturing and Six Sigma methodologies.
• Support continuous improvement initiatives across packaging and manufacturing operations.

Education

Bachelor’s degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or a related engineering discipline

Job description

We are seeking an experienced Senior Packaging Engineer to support and improve packaging operations within a regulated medical device manufacturing environment. The ideal candidate will lead packaging process development, equipment qualification, and validation activities, including IQ/OQ/PQ, while ensuring compliance with FDA requirements and quality systems. This role involves collaborating with Manufacturing, Quality, Regulatory, Operations, and Engineering teams to resolve production issues, conduct root cause investigations, develop CAPA solutions, and drive continuous improvement initiatives.

Key Responsibilities

• Lead packaging process development and improvement activities.
• Perform packaging equipment qualification and process validation, including IQ/OQ/PQ.
• Collaborate with cross-functional teams to resolve manufacturing and production issues.
• Conduct root cause investigations and develop corrective and preventive actions (CAPA).
• Maintain technical documentation and support packaging validation activities.
• Ensure compliance with FDA regulations and applicable quality system requirements.
• Drive operational excellence through Lean Manufacturing and Six Sigma methodologies.
• Support continuous improvement initiatives across packaging and manufacturing operations.

Required Qualifications

• Bachelor’s degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or a related engineering discipline.
• 7+ years of Packaging Engineering experience, or an advanced degree with relevant experience.
• Knowledge of packaging validation, manufacturing processes, quality systems, and regulatory requirements.
• Strong problem-solving, project leadership, and technical communication skills.
• Ability to collaborate effectively with cross-functional teams.

Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.