Packaging Engineer I

Primary Talent Partners; Lafayette (CO); On-site; USD 75,768 - 85,411; Full time

Job summary

A prominent recruitment agency is seeking a Packaging Engineer I for a medical device client in Lafayette, CO. This 12-month contract role involves evaluating packaging designs for regulatory compliance, leading remediation projects, and collaborating within a team. Candidates should have a Bachelor’s degree in Packaging Science or Mechanical Engineering and 1-3 years of relevant experience. Competitive pay of $55.00 - $62.00/hr is offered.

Qualifications

• Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline.
• 1-3 years in medical device or pharmaceutical industry.
• Strong team and interpersonal skills required.

Responsibilities

• Evaluate the current state of packaging design and perform gap analysis.
• Generate and execute EU MDR packaging remediation plans.
• Define remediation plans and author closing reports.

Skills

Packaging design

Quality engineering

ISO 11607 knowledge

Interpersonal skills

Microsoft Office programs

Education

Bachelor of Science in Packaging Science or Mechanical Engineering

Tools

CAD/CAPE/TOPS Software

Job description

Base pay range

$55.00/hr - $62.00/hr

Primary Talent Partners has a new contract opening for a Packaging Engineer I with our medical device client in Lafayette, CO. This is a 12-month contract with a potential for extension.

Pay: $55.00 - $62.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment.

Schedule: Onsite 4 days per week

Description

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 EU MDR packaging remediation projects and collaborates with stakeholders to achieve desired results.

Responsibilities

• 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 EU MDR 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 1-3 years in medical device or pharmaceutical industry in Packaging or Quality Engineering.
• Established and productive individual contributor with strong team and interpersonal skills.
• 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 preferred.
• Knowledge of Microsoft Office programs is required.
• CAD/CAPE/TOPS Software knowledge is preferred.

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws. If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at [e-mail]