Senior R&D Engineer

Principal R&D Engineer (Medical Device) – W2 Contract

Location: Tempe, AZ (Onsite)

Contract Duration: August 2026 – April 2027

We are seeking an experienced Principal R&D Engineer to support medical device product development and manufacturing initiatives. The ideal candidate will have strong expertise in process development, validation, statistical analysis, and cross‑functional project leadership within a regulated medical device environment.

• Design, develop, analyze, troubleshoot, and provide technical expertise during product research and development activities.
• Support manufacturing line establishment for medical devices while prioritizing safety, quality, service, and cost objectives.
• Lead process characterization and validation activities, including DOE, PCR, TMV, IQ/OQ/PQ, and performance analysis.
• Apply scientific problem‑solving methodologies such as DMAIC, process mapping, 5 Whys, 6M analysis, and root cause investigation.
• Utilize statistical techniques to drive data‑based decision‑making and quantify process confidence.
• Collaborate with cross‑functional teams including engineering, quality, manufacturing, and project stakeholders.
• Manage project activities including planning, communication, risk management, progress tracking, and issue resolution.
• Ensure compliance with quality management systems and regulatory requirements.
• Perform validation activities to ensure product reliability and manufacturing readiness.

• Advanced degree in Physics, Mechanical Engineering, Materials Science, Chemistry, Chemical Engineering, Biomedical Engineering, or related discipline.
• 5+ years of relevant medical device R&D/process engineering experience (advanced degree preferred).
• Strong experience in medical device process development and manufacturing.
• Hands‑on experience with process characterization and validation methodologies.
• Strong understanding of statistics, DOE, MSA, IQ/OQ/PQ, TMV, and data analysis.
• Experience leading projects and working effectively within cross‑functional teams.
• Strong problem‑solving, analytical, communication, and technical writing skills.

• Experience with electrical medical devices or products with electrical functionality.
• Root cause analysis and investigation experience.
• Knowledge of process validation and computer software validation.
• Experience with DRM/DFSS methodologies.
• Strong organizational skills and ability to work independently.

• Statistics and data‑driven decision making
• Strong problem‑solving and root cause analysis skills