Sr Packaging Engineer Exempt

Location: Hybrid - 3 days in either North Haven CT office or Lafayette CO office. Please confirm location on candidate resume.

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.

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

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

Work Schedule: 40 hours per week Hybrid - onsite 3 days per week (North Haven CT or Lafayette CO).

Interview Timeline: ASAP

Product Line Supported: Various within Surgical OU

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. 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 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.

Responsibilities may include designing developing and testing 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 need for resistance to external variables such as moisture corrosive chemicals temperature variations light heat rough handling and tampering. Designs package exteriors considering factors like product identification sales appeal aesthetic quality printing and production techniques. Responsibilities may also include documentation management and/or coordination of Good Manufacturing Practices (GMPs) and may support prototype line development in manufacturing facilities/plants.

Specialist Career Stream: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing projects from design to implementation while adhering to policies using specialized knowledge and skills normally acquired through advanced education (typically University).

Differentiating Factors:

• Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower-level specialists; may manage projects/processes.
• Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives through building relationships and consensus to reach agreements on assignments.
• Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple issues job areas or specialties. Makes improvements of processes systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
• Communication and Influence: Communicates with senior internal and external customers and vendors. Exchanges information of facts statuses ideas and issues to achieve objectives and influence decision-making.
• Leadership and Talent Management: May provide guidance coaching and training to other employees within job area. May manage projects requiring delegation of work and review of others work product.
• Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience.