Sr Packaging Engineer

Sr Packaging Engineer - Exempt

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).

MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

Location: Hybrid (3 days onsite in either North Haven, CT or Lafayette, CO office)

Top 3 Technical Skills Required

• Leads successful validations of packaging systems for medical devices
• Able to conduct Packaging systems Gap Analysis according to ISO11607 Part 1 and 2
• Lead project meetings and provide updates to management
  
  

Job 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 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.
• Lead successful validation of packaging systems for medical devices.
• Identify and develop innovative packaging processes and designs as part of a cross-functional team. Determine 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 with the 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.
• 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.
  
  

Additional Responsibilities:

• Designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products.
• Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering the need for resistance to external variables such as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering.
• Designs package exteriors considering factors such as product identification, sales appeal, aesthetic quality, printing, and production techniques.
• Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants.
  
  

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.

• Sponsorship is not available for this position
  
  

Check us out at www.medicalengineeringconsultants.com

AAP/EEO DFWP

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.