HYBRID Quality Engineer (Med Device)

Job Title: Sr Packaging Engineer

Type: Contract - 6 Months

Location: North Haven, CT OR Lafayette, CO

Hybrid, onsite 3 days per week at either North Haven, OR Lafayette, CO

Pay: $50.00-$66.60/hr

We are seeking a Sr Packaging Engineer for a very important client.

The packaging engineer is part of a dynamic team that provides expertise in packaging engineering and ensures quality and regulatory compliance. Supports and/or leads projects and collaborates with stakeholders to achieve desired results. Responsibilities include the following:

· Evaluate the current state of various medical device product packaging design; perform gap analysis on existing studies to the latest industry standards such as ISO11607 Part 1 and 2.

· Generate and execute packaging remediation plans for sterile barrier systems and non-sterile medical device packaging. Define remediation plans, generate/execute protocols, author closing reports, update specifications and technical documentation.

· Leads successful validation of packaging systems for medical devices

· Identify and develop innovative packaging processes and designs as part of a cross functional team. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of device protection required.

· Utilize quality and regulatory compliance knowledge to support regulatory body audits, draft technical responses and provide innovative ideas to ensure compliance to latest industry practices.

· Lead project meetings and provide updates to management.

· Assist in labeling development process.

· May perform and evaluate testing in a laboratory environment as per industry standards.

Minimum Requirements

· Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline.

· Minimum of 5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering.

· Requires practical knowledge and demonstrated competence within packaging engineering typically obtained through advanced education combined with experience.

· Knowledge and general understanding of ISO 11607 part 1 and 2, ASTM and ISTA package test methods is required.

· Established and productive individual contributor with strong team and interpersonal skills.

· Knowledge of Microsoft Office programs is required.

· CAD/CAPE/TOPS Software knowledge is preferred.

Top 3 technical skills that are required for the role:

1. Leads successful validations of packaging systems for medical devices

2. Able to conduct Packaging systems Gap Analysis according to ISO11607 Part 1 and 2

3. Lead project meetings and provide updates to management

Education Required: Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline

Years’ Experience Required: Minimum of 5 years in medical device or pharmaceutical industry in Packaging

Benefits include:

-MEC/ACP Medical

-Voluntary Dental, Vision, Life, Supplemental Income

-401k (must meet requirements)

-sick leave as required by state/county