In addition to these specific duties, you will also be charged with demonstrating strong communication skills, as well as your ability to be highly collaborative, creative, and action-oriented while working on multiple projects simultaneously.
The Principal Software Engineer will be working on a communications module analyzing, evaluating and planning solutions for very complex problems. Conducts investigations of considerable complexity pertaining to the development of new designs, methods, materials or processes, and investigates possible applications of the results. Defines business technical/patent strategy.
Leads application design, development and deployment. Ensures successful application project delivery. This individual will build strong relationships with business unit leaders and key stakeholders, to ensure alignment of enterprise application strategy to business objectives.
Drives day-to-day Project Team activities to meet project milestones and keep functions on track in compliance with Corporate and Site policies and procedures. Understands critical path activities and anticipates steps that may be bottlenecks.
Coordinate, execute, and perform lead audit functions during internal cGMP audits to assure compliance with applicable regulations and international laws and standards, guidelines, and procedures. Develop, implement, manage, and track effectiveness of corrective action plans for non-compliant issues, and provide management with regular updates.
Works closely with software engineering peers and leads to identify requirements-related issues, explore alternative resolutions and work with cross-functional team members consisting of Technical Spec Writers, Marketing, Medical, Regulatory, Program, Software Development and Software Test Management. This position is responsible for assisting with the design and development of Board Support Package for Next Gen platform, as well as that our new communication engine for Plum 360 infuser.
Maintain an ongoing search for new polymeric materials technologies which can be used in existing products for cost reductions or performance improvements or which may enable the development of new products. Where not satisfactory commercial plastic materials exist for specific applications, work with academic, external contract, industry and own expert knowledge to identify polymer chemistry solutions to challenges posed by internal commercial, operational, quality, or external regulatory requirements.
Serve as the primary product expert and function as a knowledge resource for customers, sales, R&D, product engineering, and service personnel. Requires the ability to understand, collaborate with and influence key corporate stakeholders, including R&D, operations/production.
Work with business users to understand and translate user requirements into data structures, models, and integration/extract jobs; manage the reporting and analytics platform(s) to ensure that scheduled jobs are successfully run and analytics data aligns to timeliness and completeness of requirements.
The Program Manager will be responsible for developing program justification and business case in alignment with the organization's strategic plan. The person will also monitor the business environment, program goals, and benefits realization plan in order to ensure the program remains aligned with the organization's strategic objectives. Interaction with sales, R&D engineers, project managers and Marketing Management will be required.
Supply Chain Operational Excellence Manager is responsible for working with both internal and external customers to drive efficiencies and optimization of the ICU Medical supply chain operations. The role will include identification, development, and execution of projects to achieve Company goals.
Work closely with Validation Change Owners to plan, write and supporting execution of validation documents (IQ, OQ, IOQ, PQ etc.) compliant with Plant and Corporate policies and procedures; ensure proper execution/documentation of test results, and compilation of validation packages. Responsible for reviewing, executing and approving validation documents.
Prepare, coordinate, participate, and administer external regulatory audits and inspections. Acquire and assign appropriate staffing as part of the Site Regulatory Inspection team. Maintain audit and inspection ready technology devices (laptops, projection systems, phones, etc.), procedures, presentations, supplies, and Audit Tracking SharePoint system.
The Molding Engineer will support the Company Molding Engineering Department and report to the Molding Engineering Manager. The Molding Engineer is responsible for supporting injection molding improvements through adherence to established product design, scientific injection molding process, tooling, resin, and equipment.
Develop or leads development of Validation Plans, ensuring strategies are in alignment with validation policies, procedures and external regulatory requirements and guidance's. As appropriate develop and maintain an annual plan of sterilization requalification and periodic reviews to be completed during each calendar year. Reporting on progress as required.
Prepare payroll and benefits journal entries, including monthly reconciliation of payroll related GL accounts and resolve GL report issues; work on various payroll projects and perform various payroll admin functions as needed.
The Application Programmer is responsible for the design, development and implementation of the Company's mission critical Web Applications which will be used by manufacturing plants for their day to day manufacturing activities. The Application Programmer develops and maintains Java/J2ee Web Applications including database designs.
Senior electronics designer with a solid electronic product design skills used in complex electromechanical projects involving maintenance of life of on-market products. May lead small teams of engineers in the completion of project goals.