Manufacturing Mechanical Engineer

This role focuses on designing, developing, and improving medical diagnostic devices from initial concept through full commercialization. You will create and maintain detailed engineering documentation, support testing and regulatory activities, and collaborate closely with cross-functional teams to enhance product performance, manufacturability, and cost efficiency.

This role focuses on designing, developing, and improving medical diagnostic devices from initial concept through full commercialization. You will create and maintain detailed engineering documentation, support testing and regulatory activities, and collaborate closely with cross-functional teams to enhance product performance, manufacturability, and cost efficiency.

• Design, develop, and refine medical diagnostic devices from concept through commercialization, ensuring robust, reliable, and user-focused solutions.
• Create, update, and maintain engineering drawings, specifications, and design documentation using Solid Works and established design control processes.
• Apply advanced mechanical and electromechanical design principles to develop components, assemblies, and production fixtures for medical devices.
• Troubleshoot manufacturing issues on the production floor and lead structured root cause investigations to resolve product and process problems.
• Support product testing, including verification and validation activities, to ensure devices meet performance requirements and regulatory standards.
• Contribute to regulatory compliance efforts by designing and documenting products in alignment with FDA regulations, ISO standards, and EU MDR requirements.
• Collaborate with production, quality, sales, marketing, and other cross-functional partners to ensure designs meet clinical needs, customer expectations, and manufacturing capabilities.
• Drive continuous improvement initiatives focused on product performance, manufacturability, and cost reduction, leveraging feedback from manufacturing and customers.
• Participate in the design and development of electromechanical systems, including circuit integration and fabrication processes, to support diagnostic device functionality.
• Develop and refine production fixture designs that improve assembly efficiency, quality, and consistency.
• Prepare clear, accurate technical documentation, reports, and design justifications to support internal reviews and regulatory submissions.
• Communicate design decisions, risks, and recommendations effectively to technical and non-technical stakeholders and contribute to cross-functional project planning.

• Approximately 8+ years of experience in medical device product development, with a focus on mechanical and electromechanical systems.
• Advanced proficiency in Solid Works for 3D modeling, assemblies, drawings, and design documentation.
• Strong mechanical design experience, including design for manufacturability and reliability in medical devices.
• Hands-on experience with electromechanical design, including integration of mechanical components with electronic and control systems.
• Demonstrated ability to troubleshoot manufacturing issues and lead root cause analysis using structured problem-solving methods.
• Experience working under FDA regulations, ISO standards, and/or EU MDR requirements for medical devices.
• Proficiency in production fixture design to support efficient and high-quality manufacturing processes.
• Knowledge of fabrication processes relevant to medical device manufacturing, such as machining, molding, and assembly techniques.
• Experience working with biocompatible materials and medical-grade adhesives in device design and assembly.
• Strong technical writing skills with the ability to produce clear, complete, and compliant engineering documentation and reports.
• Excellent problem-solving skills with the ability to analyze complex issues and propose practical, data-driven solutions.
• Effective communication skills and proven ability to collaborate in cross-functional teams, including production, quality, sales, and marketing.
• Bachelor of Science degree in Mechanical Engineering or a related engineering discipline.

• Experience supporting verification and validation testing of medical devices, including test method development and execution.
• Background in circuit design or working closely with electronics engineers to integrate mechanical and electronic components.
• Familiarity with continuous improvement…