Description. Represents the Regulatory Affairs function in project teams and leads regulatory projects in accordance with established timelines to meet corporate objectives. Develops and executes sound regulatory strategies to support business goals. Oversees and ensures compliance with state, federal, and international medical device regulations and overall regulatory departmental objectives for new and existing products. In addition, this posit...
Description. Summary of Position. The Global Marketing Director will play a strategic role in developing and driving EBR’s commercial launch strategy for the WiSE CRT System. They will lead their team to ensure a consistent global brand and achievement of launch metrics. This team member in this role will achieve their goals working through their team as well as in direct collaboration with key functions, regions, and countries. This is a hands-o...
Description. Position Summary. The Senior Quality Engineer will incorporate cross-functional project teams and contribute to product specification development and quality planning activities. Responsibilities include authoring and managing documentation for design verification and validation, software and process validations, human factors, and risk analysis. Lead the analysis of complaint and ensure compliance with quality management systems and...
Represents the Regulatory Affairs function in project teams and leads regulatory projects in accordance with established timelines to meet corporate objectives. Develops and executes sound regulatory strategies to support business goals. Oversees and ensures compliance with state, federal, and international medical device regulations and overall regulatory departmental objectives for new and existing products. In addition, this position also assi...
Description. Summary of the Position. The Material Handler manages incoming materials, inventory, and shipments. Responsibilities include, but are not limited to, kit pulling, cycle counting, packaging orders, and maintaining organized work areas. The role also supports safety checks, supply monitoring, and final assemblies, with occasional overtime as needed. Essential Duties and Responsibilities. Receive, inspect, and process incoming materials...
Description. Assemblers in this role should demonstrate strong technical skills, the ability to follow procedures, eagerness to learn, and a team-first attitude. This is a temp to hire position. Essential Duties and Responsibilities. Assemble, test, and inspect medical devices according to documented procedures. Adhere to our quality management system. Collaborate with the engineering team to optimize assembly processes. Maintain cleanliness and ...
Description. The Senior Manufacturing Engineer will contribute to all phases of product/process development, transfer to manufacturing, commercial launch, and sustaining support. Support transfer and scale-up of manufacturing to Contract Manufacturing partner(s). Provide technical support as necessary in solving product non-conformances, as well as realizing technical and business opportunities. Are you curious, creative, and driven. If you are p...
