Job Title: Manufacturing EngineerJob Description

The Senior Manufacturing Engineer is responsible for developing, validating, and supporting manufacturing processes for innovative medical devices. This role also supports daily manufacturing operations, providing technical expertise to resolve issues and maintain production efficiency. Compliance with FDA QSR (21 CFR 820) and adherence to the Quality Management System (QMS) are essential.

ResponsibilitiesProvide technical support for day-to-day manufacturing line operations, troubleshooting equipment and process issues.Implement and lead continuous improvement projects to enhance productivity, quality, and cost-effectiveness.Lead process validation activities (IQ/OQ/PQ) in compliance with regulatory requirements.Manage line transfer projects, ensuring smooth transition and qualification of equipment and processes.Apply structured problem-solving methodologies such as 5 Whys, Fishbone, and DMAIC to identify root causes and implement effective corrective and preventive actions (CAPA).Design tools and machines used to manufacture medical products.Review production program equipment, hardware, and tooling; make recommendations for servicing, specific repairs or replacement.Develop and optimize manufacturing processes for scalability, efficiency, and quality.Install new equipment and ensure correct operation; train others to operate new machinery.Maintain a general knowledge of new and developing manufacturing technology, equipment, and applications; apply this knowledge to recommend and implement new technology and processes.Essential Skills5+ years of experience in manufacturing process and continuous improvement.Experience in medical device manufacturing, with catheter experience preferred.Competent experience with CAD software such as AutoCad or Solidworks.Knowledge and experience in development processes and medical product documentation writing.Experience with statistical analysis and design of experiments (DOE) preferred.Lean Manufacturing or Six Sigma certification or experience preferred.In-depth knowledge of thermoplastic materials and metals.Knowledge of Good Manufacturing Processes (GMP) and Good Documentation Practices (GDP).Additional Skills & QualificationsBachelor’s Degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering or equivalent experience is required.Master's Degree in Mechanical Engineering, Industrial Engineering, or Biomedical Engineering is preferred.Ability to use PC and associated software is required.Work Environment

The work environment is meticulous and precise, offering an opportunity to join a successful, family-oriented team. The company is a leader in its field, known for its cutting-edge products, unique processes, and focus on quality and customer satisfaction. The team is composed of some of the best professionals in the world, and the company maintains strong relationships with both customers and team members.

Job Type & Location

This is a Permanent position based out of Arden Hills, MN.

Pay and Benefits

The pay range for this position is $113000.00 - $136000.00/yr.

- Comprehensive health/dental/vision- 401(k) with company match- Paid time off (PTO)- Life/disability insurance- Professional development like tuition reimbursement

Workplace Type

This is a fully onsite position in Arden Hills,MN.

Application Deadline

This position is anticipated to close on Feb 20, 2026.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.