Test & Process Engineer

• Perform complex testing of electro-mechanical devices to inform product development and root cause analysis efforts, collect and analyze data
• Contribute to mechanical design of disposable and durable system items, including prototypes, tooling and test fixtures, and support development of manufacturing equipment and processes
• Support efforts in creation of specifications and test methods for new products
• Employ DFSS principles to devise and execute tests to drive development
• Use first principles and advanced engineering methods to guide the development process
• Perform 3D modeling and tolerance analysis of complex electromechanical systems
• Support design reviews, FMEA’s, risk / hazard analysis, and similar efforts
• Work with upstream and downstream stakeholders to create designs that meet customer expectations and high-volume manufacturing requirements

• MS or BS in Engineering (Mechanical or Biomedical preferred)
• Working knowledge of DFSS tools and methods
• 1 to 3 years of experience with some work in new product development preferred
• Experience designing high volume, disposable products, especially in plastic
• Exposure to product and process validation including V&V, TMV, FAI, FAT/SAT IQ/OQ/PQ etc.
• Knowledge of Design of Experiments (DOE), Design for Six Sigma (DFSS), Design for Manufacturing/Assembly (DFMA)
• Familiarity with materials used in medical devices (best practices, biocompatibility)
• Hands on experience building prototypes and fixturing, machine shop experience a plus
• Experience with designing for manufacturing (DFM)
• Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes
• Strong hands-on design skills with mechanical components and assemblies
• Strong analytical and problem-solving skills
• Strong experimental skills leveraging proven DFSS techniques
• Proficiency in SolidWorks or other equivalent 3-D CAD modeling software and familiarity with drawing standards
• Basic understanding of structured Product Development process
• Strong self-management, prioritizing and multi-tasking skills, ability to set and meet deadlines
• Up to 5% domestic or international travel
• Need US Citizens Or GC Holders Only

Highly desirable to have experience with data acquisition, analysis and statistical techniques using LabVIEW, MatLab, Minitab etc.