Design Engineer 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. Position Summary 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.

Pay:

$80,000.00 - $120,000.00 per year

Benefits:

401(k) Dental insurance

Work Location:

In person