Senior Research and Test engineer
On-siteLeeds, England, United Kingdom
Job Summary
Perform verification tests to support regulatory submissions, investigational tests for new product development, and research to improve product designs. Develop test methods including protocols, fixtures, and validation while communicating findings and technical challenges to cross-functional teams. Lead internal projects with a strong test/research bias, mentor technical staff, and contribute to design FMEAs and process PFMEAs. Execute test procedures in line with international procedures to generate data for design verification sections of product development and design history files. Assist with departmental internal and external quality audits to ensure compliance and remediation.
Required Qualifications
- Minimum of a Bachelor's degree or equivalent in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Material Science or other related fields
- Minimum of 4 years' experience in the Medical Device industry
- Minimum of 2 years' experience within Tribology
- Experience with transducers (load cells, LVDT's, strain gages, etc.) and data acquisition systems
- Prior experience with medical device joint simulators
- Experience with data processing and statistical analyses
- Experience with technical writing
- Prior experience writing plans/protocols and performing formal testing in a regulated industry
- Good Laboratory Practice/ Good Documentation Practice
- Verbal and written communication skills
- Statistical analysis
- Problem analyzing and solving
- Ability to effectively work on multiple tasks
- Up to 10% of time may be expected for domestic and international travel
Desired Qualifications
- Prior experience or general knowledge in fixture development and qualification
- Experience with 3D motion tracking systems or 3D optical test/inspection systems
- Experience with instrument qualification and validation activities
- Experience working in an agile project management environment
- Experience with PLM applications
- Knowledge of regulatory guidelines
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