Sustaining Engineer

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Spectrum Vascular

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Description

• The Sustaining Engineer is responsible for providing engineering leadership and hands-on support to assure the successful transfer of acquired technology to a contract manufacturing partner on schedule. • This position will monitor, maintain, and/or improve the quality and performance of the PICC and Mid-line catheter product portfolio through technical evaluations, maintenance of design history files, and implementation of design improvements to address user and/or business needs. • Develop and execute project plans and activities necessary to support the vascular access business, specifically the PICC and Mid-line catheter portfolio. • Monitors, maintains, and/or improves the quality and performance of the portfolio through technical evaluations, design history file maintenance, and design improvement implementation to address user and/or business needs. • Facilitate design transfer of existing products to new manufacturing sites. • Perform technical evaluations related to supplier and manufacturing changes to existing products. • Perform design change assessments to determine impact of changes to commercial products. • Implement design changes to improve the quality of existing products and/or the customer experience. • Support new indications, regulations, and marketed regions associated with existing commercial products. • Maintain Risk Management Files for existing products based on post market surveillance. • Interfaces with external suppliers including component identification, assessment, and selection as required. • Writes test protocols and reports to support development and transfer of projects. Carries out validation and verification activities. • Generates and maintains required Engineering protocols, reports, and records as applicable. • Ensure all activities are executed in alignment with design controls, with the proper documentation for traceability. Support Regulatory filing activities (per 21 CFR 820.30, 21 CFR part 4, ISO 13485), and work closely with QA to establish and maintain design control procedures. • Assist with the development and maintenance of the budget for assigned program activities, including the preparation of cost estimates for new work. • Partner with functional areas to develop appropriate prioritization plans and appropriately escalate changes in resource demand, risks, gaps, or challenges. • Facilitate decision-making, collaboration, and problem-solving with people at all levels of the organization to accomplish shared program. • Effectively manage multiple projects and responsibilities. • Track deliverables from team members and support associated action items.

Requirements

• Bachelor’s degree in mechanical or biomedical engineering preferred. • Three years-plus of relevant medical device industry experience in device development and/or manufacturing operations. • Knowledge and understanding of molding and extrusion operations, as well as assembly, labeling, and packaging. • Good understanding of FDA regulations, QMS, GMP and ISO standards. • Experience managing diverse project activities with contract CMO facilities, and in particular process development, process scale-up/optimization, and technology transfer • Strong computer skills including proficiency in Excel, Word, SolidWorks, eQMS, and statistical methods. • Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results. • Ability to communicate, escalate and problem solve technical issues that arise. • Natural entrepreneurial spirit with unrelenting dedication to delivering results. • Desire to work in a fast-paced, innovative environment. • Natural collaborator who enjoys working on a cross-functional team.