Job Title: Manufacturing EngineerJob DescriptionThis 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
- Provide daily technical support for products, processes, materials, and equipment to help the manufacturing team achieve production goals.
- Build quality into all aspects of work by maintaining strict compliance with all applicable quality requirements and procedures.
- Troubleshoot, repair, qualify, and validate new and existing equipment used to manufacture endovascular catheters.
- Prepare testing plans, technical justifications, and documentation to support process, equipment, and material changes.
- Determine the appropriate level of testing required in alignment with internal procedures, customer expectations, and regulatory acceptance requirements.
- Collaborate with purchasing to optimize supply chains, recommend projects that reduce risk or cost, and contribute to long-term commodity strategies.
- Design, implement, and monitor Statistical Process Monitoring systems to maintain stable and capable manufacturing processes.
- Monitor daily yields and act promptly 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, addressing problems related to design, materials, or manufacturing methods.
- Prepare validation protocols and reports, clearly communicating test results, conclusions, and recommendations to stakeholders.
- Lead or participate in cross-functional project teams to drive process improvements, equipment upgrades, and product support initiatives.
- Identify, implement, and manage equipment, labor, and cycle time requirements to support production capacity and efficiency goals.
- Train and provide work direction to operators and technicians, ensuring they follow proper procedures and understand equipment and process requirements.
- Perform or support Test Method Validations (TMVs) to ensure measurement systems and test methods are reliable and appropriate.
- Identify and investigate manufacturing issues and non-conformances using root cause analysis, and disposition production material through the NCMR process.
- Notify quality assurance and quality control teams of any observed or reported product quality issues so that appropriate corrective actions can be taken.
- Summarize, analyze, and draw clear conclusions from test results to guide decision-making and continuous improvement.
- Exercise independent judgment in planning and organizing work, managing priorities, and reporting project and production status.
Essential Skills
- 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.
- Ability to accurately prioritize tasks and execute work with minimal direction in a fast-paced environment.
Additional Skills & Qualifications
- 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.
Job Type & LocationThis is a Permanent position based out of Brooklyn Park, MN. Pay and BenefitsThe 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) Job Type & LocationThis is a Permanent position based out of Brooklyn Park, MN. Application DeadlineThis position is anticipated to close on Nov 18, 2026. Workplace TypeThis is a fully onsite position in Brooklyn Park,MN.About Actalent
Actalent 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.
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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.
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