Senior Validation Engineer - Medical Lab Experience
Business Unit: Laboratory Diagnostics
Requisition Number: 226873
Primary Location: United States-New Jersey-Flanders
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%
Siemens US Talent Acquisition
Job Description Template
The Product Solution Validation Engineer is a key member of the product development team responsible for all aspects of planning and executing Validation of Medical Diagnostic instruments compliant with company and regulatory procedures.
Duties encompass the range of tasks from understanding user needs and lab workflows, developing and executing integration and validation test plans as well as executing Validation testing.
- Executes Validation test cases as a regular user of medical laboratory equipment per defined workflows and reports findings.
- Participates in Design Validation efforts by assisting with and executing test activities for R&D Integration/Validation
• Hosts internal and external Validation participants during testing in the Flanders Solutions Lab.
• Develops Validation protocols for effective customer solutions
- Works closely with project teams and customers to develop Validation workflows that provide effective test coverage to support business and quality objectives.
- Ensure adherence to regulatory requirements, budgets, and schedules
- Maintains quality results by reviewing quality control and quality assurance programs; making adjustments in policy and procedures; generating reports; maintaining records.
- Maintains medical laboratory information system by identifying information needs and problems; recommending improvements; establishing priorities; testing; reviewing user manuals;
Required Knowledge/Skills, Education, and Experience
- Bachelor of Science degree in Medical Technology, or related science field or equivalent combination of education and experience
- 5 or more years of clinical laboratory experience
Qualified Applicants must be legally authorized for employment in the Unites States. Qualified Applicants will not require employer sponsored work authorization now or in the future for employment in the United States.
Preferred Knowledge/Skills, Education, and Experience
The ideal candidate will be able to apply broad knowledge of hospital and lab practices, and procedures to the Validation lab environment.
- Technical Understanding of Siemens and/or competitor’s Diagnostic solutions
- Knowledge of Medical lab workflows
- Strong problem-solving, training, and communication skills
- Experience using Bug/Defect tracking systems
- Familiarity with Agile software development methodologies as well as project planning and estimation techniques
- Effective interpersonal, written and oral communication skills
- Experience using MS Office Tools (Word, Excel, Project, PowerPoint, Visio)
- Ability to work effectively within role independently and with other team members.