Responsiblefor design, drafting, compliance and change control of all aspects of sustaining,packaging and labeling projects across the company product line.
· Designand document packaging for both non-sterile and sterile products including thedefinition of constraints
· Create,maintain and ensure compliance of all product labeling (excluding marketingmaterial; e.g. manuals and IFUs)
· Evaluateopportunities for new suppliers, cost savings or manufacturing improvements onthe company product line; make proposals to broader operations and R&Dteams for project selection.
· Generatetest protocols, perform tests and generate reports for product verification
· Supportall company departments in all matters relating to packaging and labeling
· Managesupplier implementation of minor changes and all supporting documentation
· Performsas responsible engineer for sustaining, packaging and labeling projects includingall documentation. Initiates drawings and specifications for piece parts andassemblies. Generates change orders to existing documents. Reviewsdocumentation generated by others relating to product responsibilities.Participates in design reviews. Verifies all final design documentation, partslists, and drawings to insure completeness and accuracy.
· Performsprocurement and cost considerations analysis in the performance of tasksrelated to the assigned product. Uses internal and external resources in thedesign and development process. Performs product engineering tasks as part of adevelopment team. Notifies and updates the project manager on project schedulesto accurately show the progress of the individual tasks in relation to productand company goals and schedules.
· Evaluatesand solves problems either alone or with others. Participates inproblem-solving activities and brainstorming sessions. Approaches problemsolving in a logical manner using personal experience and/or internal orexternal resources, as necessary. Designs and performs experimental testing to debugproblems or to characterize and evaluate designs.
· Keepsthe supervisor informed as to the status of assigned tasks.
· Complieswith all design related standards as developed by external regulatory groups.
· Bachelor’sdegree in Engineering (Mechanical, Packaging, Biomedical, Manufacturing, orother related discipline)
· 2+years’ experience
· Solidunderstanding of standard development processes including change control,design verification and design validation, receiving inspection, supplierselection and qualification
· Familiaritywith standards driven aspects of medical device design, test and labeling (includingISO 60601, ISO 15223, EN 45502, ISO 14708, EU MDR, ISO 11607, ISO/TS 16775,ISTA 3A, ASTM (various))
· Abilityto understand high level business and operational needs relating to packagingand labeling
· Experienceworking directly with suppliers on design, costing, production and sustainingactivities
· Abilityto independently manage individual time and tasks
· Abilityto quickly adapt to new requirements, changing situations and supply relatedissue (in-bound or field-facing)
· Abilityto prioritize and organize effectively to work on multiple projectssimultaneously
· Abilityto operate in a fast-moving, team-oriented, collaborative environment withtight deadlines
· Skilleduser in Solidworks