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 turns improvement ideas 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 support effective engineering planning.ResponsibilitiesProvide daily support for products, processes, materials, and equipment to ensure production goals are consistently achieved.Build quality into all aspects of work by maintaining strict compliance with all applicable quality requirements and standards.Troubleshoot, repair, qualify, and validate new and existing equipment used to manufacture endovascular catheters.Prepare testing plans and technical justifications to support changes to processes, equipment, and materials.Determine the appropriate level of testing required for changes in alignment with internal procedures, customer expectations, and regulatory acceptance requirements.Collaborate with purchasing to optimize supply chains, recommend and support projects that reduce risk and cost, and contribute to long-term commodity strategies.Design, implement, and monitor Statistical Process Monitoring systems to maintain process control and improve performance.Monitor daily yields and act immediately to investigate and resolve issues in order to meet scrap reduction and output targets.Design, procure, and oversee fabrication of equipment, tooling, and fixtures needed for manufacturing operations.Perform troubleshooting on existing products and processes to resolve issues related to design, materials, or manufacturing methods.Prepare validation protocols and reports to clearly communicate test methods, results, and conclusions for process or material changes.Lead cross-functional project teams when required to drive manufacturing improvements and product support initiatives.Identify, implement, and manage equipment, labor, and cycle time requirements to support current and future production goals.Train operators and technicians or provide clear work direction to ensure proper use of equipment and adherence to processes.Perform or support Test Method Validations (TMVs) as needed to ensure measurement systems are robust and reliable.Identify and investigate manufacturing issues and non-conformances using root cause analysis, and disposition production material through the Non-Conforming Material Report (NCMR) process.Notify Quality Assurance and Quality Control promptly of any observed or reported product quality issues so that appropriate corrective actions can be taken.Essential SkillsAt least 5 years of experience in manufacturing engineering within the medical device industry, ideally with a focus on catheter products.Hands-on experience in medical device manufacturing, including familiarity with catheter product design, manufacturing processes, and clinical applications.Strong knowledge in manufacturing processes and process engineering, including equipment improvement, troubleshooting, and validation.Demonstrated ability to drive process improvement and continuous improvement initiatives in a production environment.Experience with lean manufacturing and Six Sigma methodologies to optimize processes and reduce waste.Proficiency in validation activities, including equipment validation and process validation for medical device manufacturing.Practical experience with neurovascular or endovascular catheter manufacturing and associated equipment maintenance, repair, calibration, and troubleshooting.Ability to design for manufacturability, ensuring products and processes are robust, efficient, and scalable.Ability to summarize, analyze, and draw sound conclusions from test results and production data.High proficiency with MS Office applications, including Word, Excel, Access, Project, and PowerPoint, as well as internet and email systems.Strong organizational skills with the ability to accurately prioritize tasks and execute work with minimal direction.Additional Skills & QualificationsExperience working in a catheter-focused contract manufacturing environment is highly beneficial.Knowledge in Statistical Process Monitoring and data-driven decision-making to support process control and optimization.Familiarity with global manufacturing operations and supply chains, including collaboration with international sites.Solid understanding of software capabilities and business applications relevant to manufacturing engineering and project management.Demonstrated ability to collaborate effectively with cross-functional teams, including development, quality, and supply chain.Strong communication skills for preparing clear validation protocols, technical reports, and documentation.Capability to lead or participate in cross-functional project teams to support new product introduction and manufacturing scale-up.Job Type & LocationThis is a Contract to Hire position based out of Minneapolis, MN.Pay and BenefitsThe pay range for this position is $48.00 - $60.00/hr. 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)Workplace TypeThis is a fully onsite position in Minneapolis, MN.Application DeadlineThis position is anticipated to close on Aug 15, 2026.About ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options.San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.