Test Engineer

ABOUT THE ROLE

Reporting to the Head of Product Development – Respiratory, this is an exciting opportunity to join a growing team by providing lab based testing expertise supporting the development of new & existing medical devices.

The Test Engineer will be responsible for testing on early-stage medical devices and established devices that are undergoing iterative changes to their form, materials or methods of manufacturing.

Eakin Respiratory products include a wide range of EU MDR Class I, Class IIa and Class IIb for anaesthesia and critical care. The Test Engineer will be an important influencer on suitability of new product concepts along with progressing improvements to medical devices within existing technical files.

KEY ACTIVITIES

• Design test methods, implement those methods, perform testing and document findings in a form that eases compliance with ISO13485.
• Reporting device performance (Outputs) against Design Inputs.
• Input to team activities to define acceptance criteria for testing Design Outputs (design validation and verification).
• Adopt an impartial approach to reporting results by ignoring bias and excluding unsolicited inputs from colleagues.
• Contribute to team work on work-streams within design and development projects to meet project targets and ensure design input and resulting output testing aligns with ISO13485, customer expectations and operational needs.
• Procure solutions to unmet needs for testing activity – for example working with suppliers and design/engineering colleagues to design-and-make test apparatus.
• Plan, test and report on novel/alternative raw material and manufacturing process trials.
• Ensure that QMS requirements for design file inputs, engineering change controls, development risk analysis work and associated QMS spreadsheet completion are completed in line with ISO13485 and internal QMS requirements and that any such requirements, if applicable, are documented for inclusion in product Technical Files.
• Where required, structure reporting to meet IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) requirements.
• Assist in the development, maintenance and coordinate the calibration of test jigs and testing equipment.
• Provide input to and author technical reports and design documentation for internal and external users to review, ensuring that the content is accurate and informed.
• Liaise with Quality staff on product stability testing.
• Assist the Technical Director with R&D activities/research and prototype simulation testing as required.
• Effective inputs to maintenance of the QMS in relation to design files and change control reports and
• Ensure that key information is relayed to the Technical Director and Quality Manager as appropriate.

Job Specific Accountabilities

• Provide support to design and development inputs, through provision of test capability and test protocols.
• Provide expertise and advice on new test development and on quantitative measurement, through adoption of appropriate software tools and data storage.
• Provide robust analysis of test outputs and generate test reports for inclusion into design files, engineering change control reports and other QMS controlled documents.
• Input to the selection of novel/alternative raw materials through developing a sound understanding of how the resulting medical devices are predicted to work in clinical applications.
• Support the development of new manufacturing processes with appropriate theoretical tools and techniques.
• Quality - ensuring all test and reporting documentation is of an appropriate and consistent standard.
• Ensuring regulatory compliance of test protocols, methods of data capture and storage.

Decision Making and Influence

• Required to make decisions within remit above and to escalate issues with significant risk/implication to relevant senior management.
• Use a range of standard and well-established methods to guide decisions and ultimately establish themselves as a thought leader within the company for test method development and validation.
• Objectives will be regularly reviewed and set in line with company plans.

Other

• To adhere to the company’s Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible
• To be responsible for your own health and safety and that of your colleagues, in accordance with the company’s’ Health and Safety policy
• To adhere to the company’s Quality policy and Environmental policy
• To undertake other duties as may be reasonably required

KEY SKILLS

Essential

• A degree in an engineering or scientific discipline
• Previous industry placement or internship
• Strong analytical skills
• Able to demonstrate working knowledge of experimental diligence and the ability to collect, analyse and interpret data
• Strong report-writing skills
• Strong presentation skills with the ability to discuss findings to both technical and non-technical audiences
• Strong communication skills, both verbal and written
• Competent in the use of Microsoft office packages
• Ambitious, driven individual with high levels of energy

Desirable

• Experience in a regulated quality or engineering environment
• Experience in implementing and ensuring timely completion of appropriate design and development testing requirements
• Experience in a similar role in an ISO13485 regulated medical device manufacturing environment
• Experience in developing or testing medical devices
• Experience in use of statistical analysis software
• Process validation design and implementation
• Experience in developing testing equipment, including test validation
• Previous experience in a similar role

KEY WORKING RELATIONSHIPS

Internal 

• Working alongside the Head of Product Development within the R&D team to provide coordination in the testing and validating of new medical device design file inputs, pre-production trials and changes to existing medical devices.
• Working with the Design team to ensure tests are measuring critical parameters relating to product use.
• Liaising with the Quality and Regulatory teams to ensure we maintain high standards of testing and data capture and that any relevant quality metrics are established and met and that all design and engineering change reports comply with QMS requirements.
• Ensuring that our new and existing products maintain regulatory compliance by working closely with the Regulatory team.
• Be able to work in a multi-functional team and to build relationships with peers.

External

• Suppliers
• Notified bodies during external audits
• Test houses

ADDITIONAL INFORMATION

• Ability and willingness to travel to other Eakin sites as and when required

COMPETENCIES

Manages Complexity
Making sense of complex, high quantity, and sometimes contradictory information to effectively solve problems.

Action Oriented
Taking on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm.

Resourcefulness
Securing and deploying resources effectively and efficiently.

Plans and Aligns
Planning and prioritizing work to meet commitments aligned with organizational goals.

Optimizes Work Processes
Knowing the most effective and efficient processes to get things done, with a focus on continuous improvement.

Collaborates
Building partnerships and working collaboratively with others to meet shared objectives.

Instils Trust
Gaining the confidence and trust of others through honesty, integrity and authenticity.

Nimble Learning
Actively learning through experimentation when tackling new problems, using both successes and failures as learning fodder.