Job Title: System Integration Engineer – Process
We are seeking a solutions-focused engineer to join our dynamic team. This role plays a key part in gathering and documenting requirements for workflows, enabling us to bring innovative molecular diagnostic technology to customers.
Our goal is to improve patient care and outcomes by developing diagnostic technologies that simplify molecular pathology.
This role will be responsible for:
* Gathering requirements by drafting product specifications from customer needs.
* Authoring and reviewing technical requirement specifications.
* Designing traceability matrices for requirements and test cases.
* Acting as a technical contact for internal/external customers and suppliers during product development.
* Consulting with external engineers to understand system functionality and coordinate the implementation of design specifications.
* Reviewing test cases authored by other experts to verify requirements.
* Understanding business needs and designing integration solutions by analyzing data formats and functionalities.
* Coordinating and executing activities for test campaigns to verify requirements and ensure conformance.
To be successful, you will possess:
* Knowledge of molecular biology, including real-time PCR.
* Experience in engineering or validation for IVDs or regulated products.
* Experience in software, product, process, or equipment validation.
* Familiarity with requirements management software.
* A solution-oriented mindset.
* Strong written and verbal communication skills.
You should also hold a bachelor's degree in science, engineering, or a related field; a master's or PhD is advantageous.