Manufacturing Engineer

Manufacturing EngineerThis Manufacturing Engineer role focuses on supporting the production of commercial and non-commercial finished medical devices, with primary responsibility for maturing and stabilizing a newly launched neurovascular device. The engineer investigates and resolves daily production issues involving equipment and processes, identifies opportunities to improve cost, yield, and process efficiency, and converts improvement concepts into practical solutions. The role includes performing validation activities associated with process or material changes, exercising independent judgment in planning and organizing work, monitoring performance, and reporting status. The engineer also provides technical information to development teams regarding manufacturing and processing techniques, materials, properties, and process advantages and limitations to ensure robust engineering planning.Responsibilities include providing daily technical support for products, processes, materials, and equipment to help the manufacturing team achieve production goals, building quality into all aspects of work by maintaining strict compliance with all applicable quality requirements and procedures, troubleshooting, repairing, qualifying, and validating new and existing equipment used to manufacture endovascular catheters, preparing testing plans, technical justifications, and documentation to support process, equipment, and material changes, determining the appropriate level of testing required in alignment with internal procedures, customer expectations, and regulatory acceptance requirements, collaborating with purchasing to optimize supply chains, recommending projects that reduce risk or cost, and contributing to long-term commodity strategies, designing, implementing, and monitoring Statistical Process Monitoring systems to maintain stable and capable manufacturing processes, monitoring daily yields and acting promptly to investigate and resolve issues in order to meet scrap reduction and output targets, designing, procuring, and overseeing fabrication of equipment, tooling, and fixtures needed for manufacturing operations, performing troubleshooting on existing products and processes, addressing problems related to design, materials, or manufacturing methods, preparing validation protocols and reports, clearly communicating test results, conclusions, and recommendations to stakeholders, leading or participating in cross-functional project teams to drive process improvements, equipment upgrades, and product support initiatives, identifying, implementing, and managing equipment, labor, and cycle time requirements to support production capacity and efficiency goals, training and providing work direction to operators and technicians, ensuring they follow proper procedures and understand equipment and process requirements, performing or supporting Test Method Validations (TMVs) to ensure measurement systems and test methods are reliable and appropriate, identifying and investigating manufacturing issues and non-conformances using root cause analysis, and dispositioning production material through the NCMR process, notifying quality assurance and quality control teams of any observed or reported product quality issues so that appropriate corrective actions can be taken, summarizing, analyzing, and drawing clear conclusions from test results to guide decision-making and continuous improvement, and exercising independent judgment in planning and organizing work, managing priorities, and reporting project and production status.Essential skills include at least 5 years of experience in manufacturing engineering, ideally within the medical device industry, proven work history in medical device manufacturing, with catheter-focused experience strongly preferred, hands-on experience with manufacturing processes and process engineering in a regulated environment, demonstrated ability to improve, troubleshoot, and validate production equipment and manufacturing processes, strong knowledge in continuous improvement methodologies, including lean manufacturing and Six Sigma, experience with validation activities, including equipment validation, process validation, and test method validation, technical expertise in neurovascular or endovascular catheter manufacturing processes and applications, ability to perform equipment maintenance, repair, calibration, and qualification in a production setting, skill in troubleshooting machinery and resolving equipment-related production issues, understanding of design for manufacturability and the ability to translate design requirements into robust manufacturing processes, ability to design, implement, and monitor Statistical Process Monitoring systems, experience with root cause analysis and non-conformance management through formal processes such as NCMR, strong analytical skills to summarize, interpret, and draw conclusions from test data and process metrics, high proficiency with MS Office tools, including Word, Excel, Access, Project, and PowerPoint, as well as internet and email systems, solid understanding of software capabilities and business applications relevant to manufacturing and engineering, and ability to accurately prioritize tasks and execute work with minimal direction in a fast-paced environment.Additional skills and qualifications include experience supporting newly launched medical devices, particularly in neurovascular or catheter-related product lines, familiarity with catheter product design, manufacturing processes, and clinical applications, comfort working on cross-functional teams, collaborating with quality, supply chain, development, and production personnel, experience working with purchasing or supply chain teams to optimize suppliers, reduce risk, and manage cost, exposure to global manufacturing operations and supplier quality engagement is beneficial, strong communication skills, with the ability to prepare clear validation protocols, reports, and technical justifications, ability to train and mentor operators and technicians on equipment, processes, and quality requirements, detail-oriented mindset with a focus on building quality into every aspect of work and maintaining regulatory compliance.This is a permanent position based out of Brooklyn Park, MN. The pay range for this position is $48.00 - $60.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave).This position is anticipated to close on Nov 18, 2026. This is a fully onsite position in Brooklyn Park, MN.