Medical Engineering Consultants (MEC) · 7 hours ago
Packaging Engineer
North Haven, CT
Contract
Onsite
Senior Level
5+ years expMedical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing resources, knowledge, and expertise to enhance efficiency and productivity. The Packaging Engineer will lead the validation of packaging systems, conduct gap analyses, and generate remediation plans to ensure compliance with industry standards.
ConsultingMedical DevicePharmaceuticalTraining
No H1B
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
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
Qualification
Required
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
Preferred
CAD/CAPE/TOPS Software knowledge is preferred
Company
Medical Engineering Consultants (MEC)
MEC is a comprehensive solution provider with a full suite of services from consulting and contracting to training and cost savings initiatives.
Founded in 2011Fort Lauderdale, Florida, USA
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Christopher Gustine
Managing Partner
David Campo
Managing Partner
Company data provided by crunchbase