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Description

The Senior Manufacturing Engineer is responsible for developing, validating, and supporting manufacturing processes for innovative medical devices. Additionally, the engineer supports daily manufacturing operations in a sustaining role, providing technical expertise to resolve issues and maintain production efficiency. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS). - Provide 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 (e.g., 5 Whys, Fishbone, DMAIC) to identify root causes and implement effective corrective and preventive actions (CAPA). - Designs tools and machines used to manufacture medical products. - Reviews production program equipment, hardware, and tooling; makes recommendations for servicing, specific repairs or replacement. - Develop and optimize manufacturing processes for scalability, efficiency, and quality. - Installs new equipment and ensures correct operation; trains others to operate new machinery. - Maintains a general knowledge of new and developing manufacturing technology, equipment, and applications; applies this knowledge to recommend and implement new technology and processes.

Skills

Manufacturing engineering, Manufacturing process, Medical device, Process improvement, Continuous improvement, Lean manufacturing, Six sigma, validation, equipment maintenance, manufacturing equipment, capa, dmaic, root cause analysis, iq oq, tool design, catheter, solidworks, doe, gmp, gdp, Process engineering

Top Skills Details

Manufacturing engineering,Manufacturing process,Medical device

Additional Skills & Qualifications

- Bachelor’s Degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering or equivalent experience based on management discretion is required. - Master's Degree in Mechanical Engineering, Industrial Engineering, or Biomedical Engineering is preferred. - Must have five (5) plus years’ relevant Engineering experience - Knowledge and experience in medical device manufacturing is required. Catheter experience preferred. - Competent experience with CAD software such as AutoCad or Solidworks is required. - Knowledge and experience in development processes and in medical product documentation writing is required. - Experience with statistical analysis and design of experiments (DOE) preferred. - Lean Manufacturing or Six Sigma certification or experience preferred. - Ability to use PC and associated software is required. - In-depth knowledge of thermoplastic materials and metals is required. - Knowledge of Good Manufacturing Process and Good Documentation Practice.

Experience Level

Expert Level

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 Jan 30, 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 [email protected] (%[email protected]) for other accommodation options.