POSITION OVERVIEW

SchureMed, a global manufacturer of surgical patient positioning devices, is seeking a detail-oriented and innovative Mechanical Engineer to join our Research and Development team. This role is critical to both the development of new medical devices and the support of our existing product portfolio. The ideal candidate will bring hands-on engineering expertise, proficiency in SolidWorks, and a strong understanding of regulated manufacturing environments.

QUALIFICATIONS

• Bachelor’s degree in Mechanical Engineering or related field
• 3-5 years of experience in product development or manufacturing
• Proficiency in SolidWorks and CAD software
• Strong skills in documentation, data entry, and analysis
• Experience working in a regulated environment (ISO 13485, QSR, GMP)

SKILLSCOMPETENCIES

• Proficiency in Microsoft Word, Excel, and PowerPoint
• Excellent communication, organizational, and time management skills
• Detail-oriented with strong problem-solving abilities
• Ability to work independently and collaboratively across departments
• Able to manage multiple priorities in a fast-paced setting

• Create and maintain technical drawings and 3D models using SolidWorks
• Manage Product Data Management (PDM) systems and organize engineering files
• Design and document prototypes, fixtures, and tooling using CAD tools
• Write and execute test protocols, including V&V, IQ/OQ/PQ, and Gage R&R studies
• Process and manage Engineering Change Orders (ECOs)
• Conduct inspections and document results for prototype components
• Assemble, troubleshoot, and refine product designs and systems
• Analyze test data to recommend design or process improvements
• Research, source, and implement tooling and equipment
• Prepare engineering documentation for production, including test methods and work instructions
• Collaborate with manufacturing on pilot production and process improvements
• Train team members on new procedures and tools
• Ensure compliance with ISO 13485, QSR 21 CFR 820, GMP, and other applicable regulations
• Support additional engineering initiatives as needed