8 jobs found in Fridley

POSITION PURPOSE: The Manufacturing Engineer's function is to support Operations at the site level with a focus on continuous improvements to ensure high levels of efficiency and product quality. This role is responsible for being the problem solvers to optimize a part through all the operations. This position will identify solutions to optimize efficiency while maintaining compliance to customers regulatory requirements. This position will work cross-functionally and collaboratively across the organization. ESSENTIAL FUNCTIONS AND BASIC DUTIES: Troubleshoot production delays and constraints with equipment and processes. Identify constraints and/or operational issues through line walks and other methods; work to solve and overcome through process improvements; collaborating with machinists and ops leaders Identify, implement, and track continuous improvement opportunities. Update and maintain CI Pipeline for visibility of projects identified, in process, and completed....

Job Summary The Principal NPI/Process Development Engineer position leads the development, improvements and implementation of optimal cost-effective designs and associated processes that meet the high rigor of product requirements and exceptional quality standards. This role will work specifically with active implantable products. Essential Functions Works independently to drive project completion by developing the processes used to manufacture component, sub-assemblies, and FG devices. Provides leadership and mentors less experienced engineers and technicians. Acts as the liaison between development and operations. Advocates for the process to ensure they are repeatable and can capably produce product that meets the design requirements. Prepares and presents detailed plans necessary to complete assigned projects. Develops schedule milestones, coordinates resources, facility and equipment for assigned projects. Assists in improving the system of production controls,...

Job Summary The Senior NPI/Process Development Engineer is a key member of a team developing and bringing to market Class 3 active implantable devices. The role requires collaboration and partnership with Active Implantable Design Engineers and core teams and is responsible for developing and validating the manufacturing processes and approaches to support readiness for commercial production. In addition, the NPI engineer also focuses on costs, quality, continuous improvement, and high level of customer service. Essential Functions Works independently to drive project completion by developing the processes used to manufacture component, sub-assemblies, and FG devices. Provides leadership and mentors less experienced engineers and technicians. Acts as the liaison between development and operations. Advocates for the process to ensure they are repeatable and can capably produce product that meets the design requirements. Prepares and presents detailed plans necessary to...

Job Type Full-time Description Job Summary The Senior Process Development Engineer - Delivery Systems works cross-functionally to develop and refine manufacturing processes for complex catheter-based delivery systems, including reinforced catheters, balloon catheters, steerable catheters, multi-lumen, and multi-durometer shafts. This role focuses on post-design-freeze activities such as tooling, fixture development, process characterization, and validation (IQ/OQ/PQ), ensuring robust and scalable production for high-performance medical devices. The engineer will serve as a technical subject matter expert on customer and internal project teams, driving process innovation and execution through collaboration with cross-functional partners in Quality, Operations, and Program Management. Please note: This position follows a 4-day work week schedule, Monday-Thursday, from 12:00 PM - 10:00 PM. This schedule falls within a mid-shift or split second shift. Essential Functions...

Job Type Full-time Description Job Summary The Principal NPI/Process Development Engineer position leads the development, improvements and implementation of optimal cost-effective designs and associated processes that meet the high rigor of product requirements and exceptional quality standards. This role will work specifically with complex catheters and delivery systems. Essential Functions Works independently to drive project completion by developing the processes used to manufacture component, sub-assemblies, and FG devices. Provides leadership and mentors less experienced engineers and technicians. Acts as the liaison between development and operations. Advocates for the process to ensure they are repeatable and can capably produce product that meets the design requirements. Prepares and presents detailed plans necessary to complete assigned projects. Develops schedule milestones, coordinates resources, facility and equipment for assigned projects. Assists in...

Job Type Full-time Description Job Summary The Senior Process Development Engineer - Delivery Systems works cross-functionally to develop and refine manufacturing processes for complex catheter-based delivery systems, including reinforced catheters, balloon catheters, steerable catheters, multi-lumen, and multi-durometer shafts. This role focuses on post-design-freeze activities such as tooling, fixture development, process characterization, and validation (IQ/OQ/PQ), ensuring robust and scalable production for high-performance medical devices. The engineer will serve as a technical subject matter expert on customer and internal project teams, driving process innovation and execution through collaboration with cross-functional partners in Quality, Operations, and Program Management. Essential Functions Works independently to develop, optimize, and validate manufacturing processes for catheter-based delivery systems including reflow, bonding, molding, of reinforced shaft...

Job Type Full-time Description Job Summary The Manufacturing Engineer II position supports, improves, implements and sustains optimal, cost-effective and compliant manufacturing processes in accordance with product specifications and quality standards; recommends and implements improvements to production processes, methods and controls; coordinates manufacturing launch for new or revised products. Works with suppliers to ensure seamless transactions and proper understanding of requirements. This position will be focused on manufacturing engineering support within the clean room for products that are transitioning from NPI to Commercial Manufacturing. Essential Functions Designs and carries out process improvement, root cause problem solving, project management and employee training. Aware of DFM and manufacturing robustness of process parameters for critical processes and repeatability Applies engineering principles in managing, supporting, and maintaining the...

Job Type Full-time Description Job Summary Activities include product design and development, defining technical solutions to abstract problems, defining methods and processes, design modeling, tooling design/fabrication, equipment design/fabrication, personnel management, design verification and validation, and documentation. Manage the day-to-day execution of reliability tasks by teams and team members through monitoring progress, providing technical direction, and problem-solving solutions. Subject matter expert on test method development and design verification. Primarily by driving the testing of device, assist in design and develop innovative products & manage the product design from concept to full production. This position will lead in the execution of development projects as part of a multi-functional project team with an emphasis on the V&V activities. Essential Functions Product Development (~50% allocation): Research, design and implement new...