Biomedical Engineer -validation/verification/requirements Medical Diagnostics
Siemens (Westchester, New York)

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Company: Siemens Healthcare Diagnostics Inc.

Division: SMSD - IVD OPS

Location: NY - Tarrytown

Req ID: 68780

Position Title: Product Engineer, Staff

Experience Level: Mid Level

Education Required: Bachelors Degree

Travel Required: No

Company Description:
Siemens Healthcare Diagnostics Inc. offers a broad portfolio of performance-driven diagnostic solutions that provide more effective and efficient ways to anticipate, diagnose, monitor and treat disease. Our products and services offer the right balance of science, technology and practicality across the healthcare continuum to provide medical professionals with the vital information they need to deliver better, more personalized healthcare to patients around the globe. Visit us at www.siemens.com/diagnostics.

Siemens is an Equal Opportunity Employer encouraging diversity in the workplace.


Job Description:
This “Systems Requirements and Test Engineer” has responsibility for supporting system development for in-vitro diagnostic instruments. These medical devices l provide high volume, high throughput diagnostic testing for clinical laboratories working with infectious diseases, oncology, cardiac markers, fertility testing, thyroid function, and other clinical applications.

Day to day activities of the position:
Translate the needs of clinical testing laboratories into documented engineering requirements.
Decompose and allocate System level requirements into Subsystem level requirements, ensuring complete traceability.
Assist a cross-functional engineering team (mechanical, electrical, chemical, software) in developing design concepts to meet these requirements.
Design and execute laboratory experiments to evaluate feasibility of concepts.
Perform risk analysis to assure the safety and efficacy of the device.
Determine root cause of performance issues and propose design modifications.
Write verification and validation plans and protocols to effectively test designs against requirements and customer needs.
Oversee the execution of testing.
Review test data against established pass criteria.

The successful candidate will have broad understanding across engineering, chemistry, and software disciplines, as well as an appreciation for the regulated medical device industry. The individual must function well both independently and as part of an integrated team. Good written and verbal communication skills essential. Experience with requirements management tools a plus.

The ideal background is Biomedical Engineering or other engineering, or related experience in requirements, verification and validation. Work experience in the medical device industry or pharmaceuticals industry preferred.
. Additional Information:Travel Percentage: 5%