Sr Packaging Engineer - Exempt - LanceSoft Inc

JOB DESCRIPTION
**Hybrid 3 days in either North Haven CT office or could be located and work 3 days in Lafayette CO office. Please confirm which location on candidate resume.

Top 3 technical skills that are required for the role:
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’ Experience Required: Minimum of 5 years in medical device or pharmaceutical industry in Packaging
Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Hybrid, onsite 3 days per week (North Haven CT or Lafayette CO)
What is your timeline for scheduling interviews? Week of 11/25
What product line will this person support? 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. 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.

Responsibilities may include the following and other duties may be assigned. 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 need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering. Designs package exteriors considering such factors 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. 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 the projects from design to implementation while and 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 indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. 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.