Principal R&D Engineer (1638573) — Summary:
The Principal R&D Engineer will lead process development, characterization, validation, and performance analysis for medical devices with electrical functionality. The work centers on DOE-driven process optimization, statistical analysis, and validation activities including MSA, TMV, IQ, OQ, and PQ. This engineer will guide cross-functional teams through technical problem solving, risk management, and the establishment of reliable, compliant manufacturing processes.
Requirements
- Bachelor's degree in engineering and 5+ years of engineering experience in medical-device process development or manufacturing.
- Demonstrated experience with process characterization and validation using DOE, MSA, TMV, IQ/OQ/PQ, and statistical analysis tools such as Minitab.
- Strong technical problem-solving and project-leadership skills, including data-driven root-cause analysis, risk management, and communication across cross-functional teams.
Responsibilities
- Design and execute studies to characterize processes, quantify performance, validate manufacturing methods, and support regulatory compliance and product reliability.
- Apply structured methods such as DMAIC, process mapping, 5 Whys, 6M, Is/Is Not, and timeline analysis to resolve complex technical issues.
- Lead project planning and technical execution for manufacturing-line development, monitoring critical paths and communicating assumptions, risks, and challenges early.
Important Notes
- This position is based in Tempe, AZ; final onsite/hybrid expectations and standard work hours are to be confirmed.
- The work supports medical-device products and manufacturing processes within a regulated quality management system.
- The engineer is expected to work independently while collaborating respectfully across engineering, quality, manufacturing, and project teams.
Job Disclaimer:
Equal Opportunity Employer/Veterans/Disabled
Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client
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The Company will consider qualified applicants with arrest and conviction records.
#GRPA
Pay: Up to $75.00 per hour
Benefits:
People with a criminal record are encouraged to apply
Work Location: In person
