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Packaging Engineer II
3 months ago
Must Have:2 - 5 years experience with a BS Packaging or related engineering field (e.g. Mechanical or Materials)detail-oriented Packaging Developmenteffectively communicating packaging developmentNice to Have:1. Design and development of a packaging system for terminally sterilized medical devices as per requirements established by ISO 11607-1 (Part 1: Requirements for materials, sterile barrier systems and packaging systems) and corresponding packaging ASTM and ISTA (International Safe Transit Association) standards. 2. Validation of processes for packaging medical devices that are terminally sterilized as per requirements established by ISO 11607 2 (Part 2: Validation requirements for forming, sealing and assembly processes). These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. 3. Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & Medical Device Good Manufacturing Practices3. Process Validation and Computer software validation knowledge.5. Computer literacy in MS Word, Excel, PowerPoint.JOB DESCRIPTIONThis position supports sterile and non-sterile Packaging Development for *** Spine and Biologics product lines. This position is focused on Packaging Development for a site transfer project. Standard work for this role includes ensuring all testing meets the ISO 11607 requirements, updating package assembly prints and updating Design History File documentation.Top 3 technical skills that you are required for this role:Packaging development knowledgeAbility to create and interpret technical documentsProject ManagementEducation Required: Bachelors degree in engineering fieldYears' Experience Required: 2-5Will the contractor be working 40 hours a week? If not, weekly estimate? Yes, 40hrsDoes this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Hybid - Onsite at least 3 days per weekWhat is your timeline for scheduling interviews? ASAP would like to start Aug 1stWhat product line will this person support? Various Spinal implants and instrumentsResponsibilities 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: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
