Packaging Engineer

Pay range: $50 - $62/hr. W2 contract

Leading medical device manufacturer is seeking a Packaging Engineer in Winston-Salem, NC.

Description:

• Responsible for implementing and maintaining the technical qualification of Tier II suppliers and supplier processes.
• Leads and participates in planning and conducting work requiring judgment in the independent evaluation, selection and substantial adaptation and modification of standard techniques, procedures, and criteria for supplier validations.
• Works with suppliers to identify and resolve technical issues and drive activities at the supplier for continuous improvement opportunities.
• Independently identify, plan and conduct medium to large-size projects that require custom, risk-managed execution plans, investigations and/or equipment; manage multiple often concurrent projects.
• Independently conceives and develops approaches to the solution of problems which require application of advanced technical knowledge.
• Applies working knowledge of related disciplines.
• Understand the business needs of the company and have a thorough understanding of customer needs as they relate to projects.
• Lead and/or participate on cross-functional teams to support organizational goals.
• Interfaces with product team members, department managers, designers, R&D, marketing, internal regulatory.
• Design and lead complex experiments, often with multiple variables; independently execute and/or direct others in the execution of project tasks by applying novel engineering theories, concepts and techniques.
• Conceptualize complete solutions; create or coordinate the design solutions for novel or complex problems; explore multiple alternatives.
• Serve as subject matter expert (SME) or independent technical expert (ITE) on a project's technical matters; may interface with senior management, external firms or agencies.
• Coordinate technical matters between organizations.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Plans, schedules, conducts or coordinates detailed phases of the engineering work in a part of major project or in a total project of moderate scope.
• Responsible for compliance with applicable Corporate and divisional policies, GMP and performing duties as assigned by management
• Understand and comply with applicable EHS policies, procedures, rules and regulations.
• Assist in process assessments and improvements and drive them to completion

Qualifications:

• Ideally a BS in Packaging Engineering.
• 2 – 5 years of experience, or less with experience working in web handling environment particularly with adhesive and/or extrusion lamination of materials.
• Strong technical knowledge and application of concepts, practices, and procedures.
• Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors.
• Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior.
• Demonstrated initiative and problem-solving skills; critical-thinking skills.
• Ability and aptitude to use various types of databases and other computer software.
• Experience of analyzing First Article Inspection (FAI) and PpK data
• Familiarity with cGMP, FDA and ISO regulated environment
• Experience working in tooling manufacturing sites including interacting with toolmakers suppliers for design and FAT qualification actives.
• Equipment design and specification with Validation experience.
• Able to demonstrate DOE and greenbelt DMAIC methodologies.
• Knowledge of Web handling environment particularly with adhesive and/or extrusion lamination of materials.
• Previous experience in introducing new materials is preferred.
• Prefer experience in regulated environments such as med device; etc. ISO9001 and ISO13485 knowledge.