Principal R&D Engineer

**CANDIDATES CURRNETLY WORKING UNDER F1 OPT/F1 OPT STEM/H1-B WILL NOT BE CONSIDERED. W2 CANDIDATES ONLY**

MDR Principal R&D Engineer (Through April 2026, with strong potential for extension // Tempe, AZ):

Top 3 Required Skills:

1. Process development (i.e. process characterization and validation – DOE, PCR, TMV, IQ, OQ, PQ)
2. Statistics
3. Strong problem-solving skills

Education Required: Advanced degree in Physics, Mechanical Engineering, Materials Science, Chemistry, Chemical Engineering, Biomedical Engineering, or similar discipline

Years’ Experience Required: 5 years of R&D experience

Duties:

• Lead the innovation, development and/or optimization of new manufacturing concepts, processes, and procedures for transfer to manufacturing operations.
• Champion the use of Design for Reliability and Manufacturing (DRM) and data driven methods through process development
• Work with process owners and product development teams to define robust process flows for new products
• Work with technology development to understand new process technologies for research and development towards release to manufacturing operations.
• Own requirements flow down from product design to process development, including working with process owners to disposition inputs / outputs to deliver efficient, cost effective and robust control and monitor strategies
• Own equipment scouting, down selection, qualification, and characterization.
• Own process characterization and process validation activities to ensure maturity and stability of processes when released to manufacturing (DOE, TMV/Gage R&R, IQ, OQ, PQ, etc.)
• Own the interfaces and interactions between processes and determine product integration risks
• Lead risk assessments and risk burn down activities for process interfaces and interactions
• Provide input into product and process design based on an understanding of the integration risks
• Applies statistical methods and science-based decisions to design experiments and implement improvements
• Coordinate and/or perform necessary experiments and product builds to establish robust processes
• Implement and own yield monitoring systems and procedures for equipment and processes developed
• Monitor, root cause, and resolve process yield issues during product and process development
• Lead the identification and implementation of corrective actions for yield issues in collaboration with process owners and product engineers
• Reviews product development requirements for compatibility with processing methods to determine costs and schedules
• Interacts with product design and development personnel to ensure that processes and designs are compatible
• Generates and maintains documentation per quality system regulations
• Ensures processes and procedures are in compliance with regulations

Must Haves:

• Experience with laser welding systems
• Medical device process development and manufacturing, experience of products with electrical functionality an advantage
• Examples of critical thinking and use of statistics
• Working in a cross functional team and leveraging basic PM skills e.g. project planning, communication, risk management, etc.
• Work collaboratively and with respect & humility within a cross functional team to establish manufacturing lines for medical devices prioritizing safety, quality service, cost
• Engage with team to understand goals and current reality, provide solutions and align on path forward, drive/track/communicate progress, adapt as needed with team
• Read and understand quality management system documents that provide details of business processes to be used and comply with those procedures
• Use scientific problem-solving methodologies e.g. DMAIC, process map, 5 whys, 6M, timeline, Is/Is not, etc. Use statistical techniques to quantify confidence, declare assumptions, be data driven in decision making
• Attention to detail, accuracy, to ensure own work meets required standard (compliant to quality management system, grounded in scientific facts and/or data, within safety/scope/schedule/cost guidance)
• Understand priority, drive critical path, and monitor secondary critical paths for progress, communicate early any challenges