Design Engineer

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

Job Description

Job Description

Fiagon NA, LLC designs, develops, manufactures, and markets advanced medical devices for use in the healthcare industry. Our business is expanding and we are seeking a Manufacturing / Process Development Engineer to support our increasing demand and implementation of new medical device products to market.

We are seeking a motivated, detail-oriented Design Engineer to join our product development team. The ideal candidate will have expertise in SolidWorks, experience in the product design for manufacturing, and a passion for transforming concepts into manufacturable products. This role is responsible for designing medical device components, manufacturing fixtures, and production equipment; creating and maintaining engineering documentation; supporting product development and manufacturing operations; and collaborating with cross-functional teams to drive innovation and continuous improvement.

** Key Responsibilities**

• Design, develop, and maintain detailed 3D models, assemblies, and engineering drawings using SolidWorks.
• Support the development of medical devices from concept through production, ensuring designs meet product performance, regulatory, and quality requirements.
• Design manufacturing fixtures, tooling, and production equipment to improve efficiency, quality, ergonomics, and safety in medical device manufacturing processes.
• Create and maintain complete engineering documentation, including engineering drawings, specifications, bills of materials (BOMs), assembly instructions, and engineering change documentation.
• Generate accurate manufacturing prints and assembly drawings to support fabrication, inspection, validation, and production activities.
• Develop and evaluate prototypes using various fabrication methods, including 3D printing.
• Support hands‑on prototyping, assembly, testing, and validation activities for both products and manufacturing equipment.
• Collaborate closely with Engineering, Manufacturing, and Quality Assurance teams to support new product development, process improvements, and issue resolution.
• Participate in design reviews, risk assessments, and product verification and validation activities.
• Troubleshoot design, manufacturing, and process‑related issues and implement effective solutions.
• Support continuous improvement initiatives by identifying opportunities to improve products, manufacturing processes, tooling, equipment, and documentation.
• Maintain accurate documentation in accordance with company quality system requirements and applicable medical device regulations.
• Effectively communicate project status, technical information, design concepts, and recommendations to stakeholders.

** Required Qualifications**

• Bachelor’s degree in Mechanical Engineering, Industrial Design, Biomedical Engineering, or equivalent experience.
• Minimum of 3 years of design and manufacturing experience
• Advanced proficiency in SolidWorks, including part modeling, assemblies, detailing, and revision control.
• Experience creating detailed 3D CAD models, engineering drawings, and BOMs.
• Knowledge of Design for Manufacturing (DFM) and Design for Assembly (DFA) principles.
• Familiarity with machining, injection molding, fabrication processes, and manufacturing equipment design.
• Experience with 3D printing technologies and prototype development.
• Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).
• Strong understanding of engineering drawing standards and manufacturing documentation practices.
• Excellent verbal and written communication skills.
• Strong organizational skills and exceptional attention to detail.
• Self-motivated with the ability to work independently and manage multiple priorities.
• Demonstrated ability to collaborate effectively in a cross‑functional environment.

Success Factors

The successful candidate will consistently deliver accurate and well‑documented designs, support manufacturing through effective fixture and equipment development, create comprehensive engineering documentation and BOMs, proactively drive continuous improvement initiatives, and collaborate across departments to successfully develop and manufacture high‑quality medical devices.

Company Description

Fiagon NA, LLC believes in the synergy of teamwork while maintaining an entrepreneurial spirit and providing an environment in which our associates develop and accomplish professional objectives. We offer a competitive salary and benefits package including health, life, retirement, and related benefits.

Company Description

Fiagon NA, LLC believes in the synergy of teamwork while maintaining an entrepreneurial spirit and providing an environment in which our associates develop and accomplish professional objectives. We offer a competitive salary and benefits package including health, life, retirement, and related benefits.