Job Scope
The technical Expert acts as reference for System Engineering and System Integration (SI) activities in the development of molecular diagnostic solutions.
Directly support the System Engineering / System Integration manager by defining planning coordinating and delegating work within the SI group.
Lead feasibility verification validation and system optimization activities ensuring technical quality and documentation completeness. Collaborate with cross-functional teams to ensure effective integration of hardware software consumables and assays supporting complex problem resolution and technical training of the team.
Key Duties and Responsibilities
Contribute to the definition and improvement of system integration best practices.
Act as technical expert for system integration on molecular diagnostic platforms.
Work on the development of systems designed for medical diagnostics including: instruments related equipment and fixtures software consumables and assay protocol and chemistries.
Write System requirements/specifications
Participate in risk assessments and investigations of system anomalies.
Lead feasibility V&V and system optimization activities defining operational plans in collaboration with functional leaders.
Write and supervise technical documentation ensuring completeness and compliance with quality standards.
Assess system reliability and support reliability testing activities
Present work and experimental result to key stakeholders through high quality PowerPoint presentations
Work cross-functionally with other company functions (including R&D Quality Assurance Corporate Service Business and Operations) in driving successful product development and owning technical expertise on systems integration competencies
Work with 3rd party instrumentation suppliers on instrument development as required by the project
Education Experience and Qualifications
Masters Degree in Engineering or Sciences preferably with emphasis on Systems Engineering; PhD appreciated but not required
35 years of experience in system integration product development or validation roles in diagnostics or medical device industry.
Technical Competencies:
In-depth knowledge of complex system development (instrumentation software consumables assay).
Experience in V&V activities requirements management and risk analysis.
Demonstrative technical proficiency scientific creativity collaboration and a successful track record that has involved independent thinking.
Skills:
Highly motivated and success driven
Understanding of system level product development
Advanced problem-solving and critical thinking.
Attention to detail and quality orientation.
Ability to understand interfaces between components in a complex product
Ability to present complex problems through highest quality PPT presentations and effectively lead to proper decision making
Scientific background in molecular field is an advantage
Ability to escalate issues appropriately
Strong analytical problem solving and decision making skills
Good organizational and interpersonal skills
Good communication skills.
Languages: English: fluent or mother language both written and spoken
Italian: fluent or mother language both written and spoken
Travel availability: Limited international travel may be required (<10% of working time)
Hybrid work
Required Experience:
Exec
Luminex Licensed Technology: Diasorin provides innovative xMAP® Technology solutions for fast, reliable answers in research, impacting daily patient health outcomes.