To help continue our growth and success, we are looking for a Device Test Engineer (Device Development) to join our dedicated team on its journey to achieve invoX’s vision to become a globally recognized, fully integrated pharmaceutical company, with an advancing pipeline of innovative products addressing unmet healthcare needs, directly improving patients’ lives.
The role will support our R&D teams by supporting the formal device test activities of key SMI development projects as part of a wider cross-functional team.
Main Accountabilities and Responsibilities
Accountabilities and Responsibilities include, but are not limited to:
· Device test engineer for one or more device development projects from concept development to design transfer.
· Work closely with the device development team to help drive “design for test & diagnosis” into the product
· Work with a small team of test engineers to plan and execute programme test activities
· Help develop key test processes, tools and protocols in accordance with the internal Quality Management System.
· Support the running of the associated device test repository, containing device related test processes, protocols and test data.
· Collaboration with programme lead, device engineering and cross functional teams to align test activities
· Co-ordination of relevant external partners (e.g. labs, test houses) to deliver on project test objectives.
· Manage (identify and mitigate) project test related risks, both technical and programme related,
· Own/develop the test activities, data and reports to present at key programme test reviews e.g. test readiness reviews, design reviews
· Develop and control of programme test plans, test execution and test reports/reviews
· Work with the functional managers to manage, budget and maintain the test equipment, ensuring it is validated to the level required for the respective test activity
· Foster integration with the device engineering team in Belgium.
Experience/Qualifications
· Diploma in Engineering or Science discipline or related subject
· Test engineering development experience with precision and/or safety critical products; ideally solid experience within a regulated environment
· Data analyst; ability to quantify and evaluate product quality & reliability
· Experienced in working with different levels of test (e.g. unit, system) and flexible “fit for purpose” test environments (data quality needed vs. test method level of validation)
· An advantage:
o Experience working in medical design control process
o Hands on with test tracker tools
o Test design; setup and validation/measurement system analysis techniques e.g. gauge R&R
Key Technical Skills
The following key technical skills are required (M)andatory or (A)dvantage for the role;
· (M) Demonstrable understanding of test fundamentals, tools & techniques
· (M) Data analyst; hands on statistical analysis (e.g. JMP, minitab)
· (M) Hands on MS Office tools (e.g. Word, MS Project, Excel)
· (A) Hands on test tracker tool(s)
· (A) Hands-on, problem-solver. Proficient with root cause tools e.g. 8D
· (A) Six sigma green belt
Key Interpersonal & Leadership Skills
The following key interpersonal and leadership skills and capabilities are considered essential to the role:
· Analytical, disciplined and detailed
· Methodical, disciplined, structured mindset
· Pro-active, self-starter, takes the initiative
· Leadership skills; confident & considerate
· Able to work to objectives, prioritize & manage workload
· Excellent communication and networking skills.
· Strong numeracy and literacy
· Fluent in English, spoken and written