• Independently manages scope, time and resources of medium to large scope projects, within predefined constraints.• Utilize Change Development Process for controlling changes post market launch for products and processes.• Support global manufacturing operations, quality and regulatory functions for products in the market.• Provide practical, sustainable and creative options to solve problems and create business opportunities.• Execute product maintenance and enhancements post market launch at internal and external manufacturing locations.• Responsible for the interface between R&D Engineering and the Manufacturing team, as well as prioritization of product optimization initiatives across Sourcing, Manufacturing, Marketing, Quality and Regulatory.

▪ EUMDR Regulation▪ Develop full-scale project plans and associated project management deliverables required for the successful project execution, including schedule creation, gathering development cost estimates, and target cost information▪ Effectively communicate project expectations to team members and stakeholders in a timely and clear fashion▪ Create and manage schedules based on approved project scope▪ Plan and schedule project timelines/ schedules using appropriate tools▪ Manage project dependencies and critical path▪ Track project milestones and deliverables against the approved baseline▪ Identify risks in the project schedules and assist in the creation of mitigation plans▪ Proactively manage changes in project scope, identify potential crises, and device contingency plans▪ Manage the gaps between functions to guide projects though the phase gated development process up to and including the launch to Sales▪ Manage and Maintain project resource plan▪ Ensuring that engineering department goals, metrics and objectives are met.▪ Establish and audit standardized tools and templates to use when leading cross functional team meetings ▪ Help drive the sharing of best practices across the project management team

▪ Work with R&D to develop a strong portfolio of product development projects that support the strategic direction and grow the business.▪ Take an active role on product development teams as leader or key participant▪ Creation of project plans and schedules▪ Ability to fully scope out, at all levels, the requirements of a given project and provide an implementation plan for execution▪ Designing, editing, and reviewing protocols and other documentation to test new concepts, validate processes, qualify products, or commercialize products▪ Provide support to production for business continuity activities▪ IQ/OQ/PQ development and execution, including training support▪ Assigns projects and establishes prioritization▪ Responsible for the creation, implementation and communication of project plans▪ Contributor to a culture of innovation by proactively generating concepts for new products▪ Identify effective project strategies ▪ Lead and collaborate with team members and key partners for the program in defining key project constrains▪ Function as the lead contact for all internal partners▪ Lead the project team to identify and address issues▪ Responsible for ensuring plans and deliverables are complaint with appropriate design procedures▪ Lead system/product-level feasibility and risks assessments

▪ Complete life-cycle responsibility for new project introduction▪ Develop full-scale project plans and associated project management deliverables required for the successful project execution, including schedule creation, gathering development cost estimates, and target cost information▪ Effectively communicate project expectations to team members and stakeholders in a timely and clear fashion▪ Create and manage schedules based on approved project scope▪ Plan and schedule project timelines/ schedules using appropriate tools▪ Manage project dependencies and critical path▪ Track project milestones and deliverables against the approved baseline▪ Identify risks in the project schedules and assist in the creation of mitigation plans▪ Proactively manage changes in project scope, identify potential crises, and device contingency plans▪ Manage the gaps between functions to guide projects though the phase gated development process up to and including the launch to Sales▪ Manage and Maintain project resource plan▪ Ensuring that engineering department goals, metrics and objectives are met.▪ Establish and audit standardized tools and templates to use when leading cross functional team meetings ▪ Help drive the sharing of best practices across the project management team

▪ Responsible for creating, reviewing, executing and summarizing validation protocols and providing input, critical review and approval of any related validation activities associated with the production of Medical Devices.▪ Performing process capability studies and conducting design of experiments ▪ Interfaces with Management, Quality Assurance, Process Development, Product Development, Engineering, Commercialization, Contract Services, Regulatory Affairs, Package Engineering, Scheduling, Packaging and Processing. ▪ Develops validation master plan and re-qualification schedule▪ Plans upcoming validation projects and develops timelines for implementation▪ ¬Ensures that validation projects and timelines are structured in accordance with FDA ▪ Informs Quality Assurance management of status of validation projects on a regular basis▪ Designs experiments during the pre-validation phase to determine optimum operating settings for maximum fiscal efficiency and product quality▪ Supports the Commissioning, Qualifying, Validating (C.Q.V.) process▪ Plays an integral role in designing, implementing, and providing training for the process▪ Assists in the design, analysis and approval of IQ, OQ, PQ and Computer System Validation

▪ Partner with Design Assurance (Quality) to identify areas of reliability, risk, and sampling.▪ Generate design verification and stability project plans including planning for requirement verification, reliability and/ or stability activities.▪ Develop test strategies to determine the best means of providing design verification and reliability (e.g. success testing, test to failure, alarm conditions, etc).▪ Validate test methods using equipment qualification, software validation, and measurement analysis.▪ Develop and qualify new test protocols, ensuring test objectives are effectively incorporated. Design and coordinate the fabrication of unique test fixtures required for protocol execution.▪ Create custom control, user interface, and data collections programs using Lab View.▪ Coordinate assigned projects resources (technical and equipment) with the objective of assuring data integrity and maximizing test throughput efficiency.▪ Work with lab technicians to assemble, test, and troubleshoot mechanical, electronic, electromechanical, and pneumatic test set­ups and data acquisition system.▪ Analyze test data for conformance to pre­determined acceptance criteria ▪ Assist engineering team in failure investigations

▪ Manages various engineering projects for the manufacturing facilities▪ Plans and implements projects for plant expansions and improvements▪ Works closely with Environmental, Health and Safety ▪ Performs continuous improvement practices using KAIZEN methodology▪ Maintains reliable and safe manufacturing systems while improving production rates, efficiencies, yields, and costs▪ Supports QMS and process reliability system▪ Ensures employees complete required training