Senior Product Development Engineer
This role has primary responsibility for confirmation that medical devices and combination products meet their intended function. This includes development of data through engineering studies that informs new product development as well as test reports that support product submissions. The candidate will work within a team environment to solve problems and utilize best engineering practices and techniques for root cause and statistical analysis. This work entails defining test methods, developing protocols, performing data analysis, and writing reports in compliance with corporate procedures.
- Partner with Systems engineers in defining product requirements such that they are verifiable
- Development of test fixtures, test methods, and performance of Test Method Validation activities
- Coordinate with internal and external partners and suppliers to procure test samples and manage conditioning and accelerated aging studies
- Ensure integrity and compliance of data according to Standard Operating Procedures
- Develop Verification Plans including test strategy
- Utilize technical writing and statistical data analysis skills to write protocols and reports
- As necessary, conduct root cause analysis and derive recommendations based on analysis of data
- Translate inspections and tests methods into component and product specifications
B.S. in Engineering discipline and 2 to 5 years related experience. Familiarity with ISO standard test methods and related test instrumentation preferred. Excellent analytical and communication skills required. Ability to work and solve problems in team environment. Technical writing skills are required for protocol and report writing.
Sthree US is acting as an Employment Business in relation to this vacancy.