Device and Product Performance Scientist
Core
Lead the development and validation of test methods for combination products (devices and medicines) and provide technical laboratory expertise to support design verification and product reliability.
Role type
Senior IC device and product performance scientist (combination products)
Builds
Combination product test methods, verification reports, and technical documentation for regulatory submission
Domain
Medical devices / Combination products / Regulatory compliance (FDA/ISO)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
analytical method development and validation, statistical data analysis, GMP environment experience, design control requirements knowledge, technical documentation compilation, device investigation leadership, equipment calibration and qualification, risk assessment
Preferred skills
Minitab proficiency, FDA 21 CFR part 820 knowledge, ISO 13485 knowledge, metrology testing experience, engineering verification experience, biological evaluation experience, transport and shipping study experience
Technologies
Trackwise, Minitab, GDD
Responsibilities
Lead development and validation of test methods for combination products; Provide technical mentorship to junior team members; Conduct trending and statistical analysis of analytical data; Lead device investigations and participate in technical investigation teams; Ensure products meet reliability requirements through appropriate controls; Support R&D lab activities including equipment calibration and qualification; Compile and review technical documentation in line with global regulatory requirements
Seniority
Senior, hands-on IC with mentorship responsibilities
