Design Engineer (Medical Devices) – CAD & Manufacturing

Fiagon NA, LLC; Saint Paul (MN); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Health benefits

Life insurance

Retirement plan

Job summary

Fiagon NA, LLC is seeking a Manufacturing / Process Development Engineer to support growing medical device product development. The design-focused role emphasizes SolidWorks modeling, fixture and equipment design, and creating robust engineering documentation to drive manufacturability and quality.

The candidate will work with Engineering, Manufacturing, and Quality teams to advance new products from concept through production, including prototyping and design reviews, while maintaining

Qualifications

• Bachelor's degree in a related engineering field is required.
• Minimum 3 years in design and manufacturing environments.
• Advanced proficiency in SolidWorks with experience in drawings and BOMs.
• Familiarity with machining, molding, fabrication, and equipment design.
• Excellent written and verbal communication, and ability to work cross-functionally.

Responsibilities

• Design, develop, and maintain 3D models, assemblies, and drawings in SolidWorks.
• Support medical device development from concept to production, ensuring regulatory and quality compliance.
• Design fixtures, tooling, and production equipment to improve efficiency, quality, and safety.
• Create and maintain engineering documentation, BOMs, and change control records.
• Generate manufacturing prints and assembly drawings for fabrication, inspection, and validation.
• Develop prototypes using 3D printing and other fabrication methods.
• Support hands-on prototyping, assembly, testing, and validation activities.
• Collaborate with Engineering, Manufacturing, and Quality Assurance teams on development and improvements.
• Participate in design reviews, risk assessments, and product verification/validation.
• Troubleshoot design and process issues and implement effective solutions.
• Drive continuous improvement in products, processes, tooling, and documentation.

Skills

SolidWorks

DFM/ DFA

Engineering documentation

Cross-functional collaboration

3D printing prototyping

Manufacturing fixture & equipment

Strong communication

Education

Bachelor's degree in Mechanical Engineering, Industrial Design, Biomedical Engineering, or equivalent

Tools

BOM management tools

3D printing software

Job description

Fiagon NA, LLC is seeking a Manufacturing / Process Development Engineer to support growing medical device product development. The design-focused role emphasizes SolidWorks modeling, fixture and equipment design, and creating robust engineering documentation to drive manufacturability and quality.

The candidate will work with Engineering, Manufacturing, and Quality teams to advance new products from concept through production, including prototyping and design reviews, while maintaining