We are looking for an accomplished Mechanical Engineer with over 10 years of experience in design engineering and more than 7 years in FDA and ISO 13485 regulated environments. Proven track record in product development, leadership in new technology and process innovation, and expertise in injection molding, metal forming, welding, and automation design. Proficient in SolidWorks, Product Data Management (PDM) systems, and FDA Quality System Regulations. Strong communicator with the ability to work independently and meet objectives consistently.

Key Qualifications

• Bachelor’s Degree in Mechanical Engineering (B.S., M.E.)
• 10+ years of experience in design engineering
• 7+ years of experience in FDA and ISO 13485 design and manufacturing environments
• Proficiency in SolidWorks design software, including advanced surface modeling and simulation
• Experience with Product Data Management (PDM) solutions
• Leadership in the development of new products, technologies, and associated processes
• Advanced knowledge of injection molding, metal forming, welding, and other metal and plastic joining methods
• Expertise in design for automation
• Proficient in Microsoft Project and Microsoft Office Suite
• Working knowledge of FDA Quality System Regulation (QSR) and ISO 13485 guidelines related to Design Controls
• Strong written and verbal communication skills
• Ability to work independently with minimal supervision and consistently achieve goals

Preferred Qualifications

• M.S. Degree in Engineering
• 15+ years of medical device engineering experience
• 10+ years of experience in FDA and ISO 13485 design and manufacturing environments
• Experience with Class II and Class III electromechanical devices
• Experience in launching and maintaining PDM systems, preferably SolidWorks