Endomag uses a 'semi-virtual' business model for product development and manufacturing. Our cutting-edge medical device products are developed and manufactured via a network of third-party suppliers, contract development organisations, and consultants who work on behalf of Endomag. Endomags’ on-site laboratory is primarily used for preliminary feasibility studies and V&V tests.
The job holder will have responsibility for V&V testing of Endomag’s future products, including implementation of test rigs and scripts in the laboratory, data collection, analysis and documentation.
He/She will contribute to multiple projects and coordinate with the other members of the R&D team at Endomag.
Endomag is certified to ISO 13485 and V&V activities will need to be operated and documented to relevant medical device standards.
Key responsibilities and duties:
- Review requirements and scrutinize for testability.
- Develop V&V test plans, test procedures, and test reports.
- Execute test procedures both personally and using test technicians.
- Log defects and issues found during V&V activities and track to closure.
- Quickly learn to use automated test tools and specialty test equipment; develop and validate automated test scripts.
- Perform regression analysis and determine testing associated with design changes.
- Provide regular project status reports.
- Prioritize project tasks to complete on schedule while maintaining quality of work.
- Learn from and adhere to internal quality manual (Quality System Procedures, Work Instructions, Forms).
- Work in a team environment; peer review work.
- Work on multiple, concurrent projects.
- Play an active role early on in ensuring requirements are complete, unambiguous, and testable, collaborate to develop detailed test plans, and assist with development testing prior to the verification and validation phase.
Individual Specification
Qualifications
Bachelor’s Degree in an engineering discipline or equivalent.
Experience and Knowledge
• 1-3 years professional experience
• Basic understanding of global medical device regulations, requirements, and standards
• Testing hardware at the system level, with some knowledge of sub-system and software level
• Experience with developing scripts for data collection and analysis e.g. Labview, Matlab, Python, Excel
• Experience of technical writing
• Excellent IT skills (MS Office)
Abilities and Skills
• Excellent written and presentation skills, demonstrated in a wide range of contexts
• Ability to be hands-on when required
• Evidence of effective communication and inter-personal skills
• Evidence of ability to work with critical attention to detail and high levels of accuracy
• Proven excellent organisational and time management skills to effectively handle conflicting priorities and ensure tight deadlines are met
• Experience in working for a growing, dynamic organisation
Other
• Willingness to occasionally travel within the UK.