28 days old

Test Eng, Sr

Newark, DE
**Test Eng, Sr**

Locations:Newark, Delaware

Job Family: Engineering


English (US)

**Job Description**

**Division:** Siemens Healthineers

**Business Unit:** Laboratory Diagnostics

**Requisition Number:** 212560

**Primary Location:** United States-Delaware-Newark

**Assignment Category:** Full-time regular

**Experience Level:** Senior level

**Education Required Level:** Bachelor's Degree

**Travel Required:** 15%

**Division Description:**

Division Description

Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.

With 45,000 employees Siemens Healthineers is one of the worlds largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers needs. So that more people can have a life that is longer, richer, and more filled with happiness.

For more information, please visit: http://www.usa.siemens.com/healthcare

**Job Description:**

**Siemens US Talent Acquisition**

Job Summary

The Verification and Validation (V&V) Lead Engineer will be engaged in verifying custom designed, software-driven production test equipment deployed into manufacturing sites to assess the performance of electro-mechanical assemblies. V&V Lead Engineer will lead a team providing guidance, priorities and oversight to all V&V activities across multiple projects. V&V Lead Engineer will ensure group V&V procedures are current, relevant, complete and effective. V&V Lead Engineer will interact with other cross-functional team members and stakeholders to influence design, process and project decisions related to V&V activities. V&V Lead Engineer will estimate plan and schedule V&V projects. V&V Lead Engineer will verify the functional correctness of production support software systems. All V&V activities are to be conducted according to FDA requirements and internal quality standards. This position provides support to the New Product Development Technical Operations team to meet project deliverables in the completion of development testing. Project deliverables include producing verification and/or validation plans, protocols, and reports; execution of the plans and protocols; and resolving deviations. The V&V Lead Engineer ensures V&V procedures are aligned to internal and regulatory process requirements.

Job Duties

+ Prepare validation and performance qualification protocols for new and/or modified processes, systems or equipment.

+ Author/review and approve technical deliverables such as functional specification,verification plan, user requirement specification, functional requirement specification, design specification, test method validation, installation qualification protocol and summary report, operational qualification protocol and summary report, performance qualification protocol and summary report, test plan, test scripts which interact with Siemens proprietary Global Testing Platform

+ Assist in design and development of complex test systems, Initiate system analysis, lead the definition of user requirements and assesses impacts. Determine alternate solutions with risk analysis and identify opportunities to use technology to improve availability and advance business initiatives

+ Ensure system compliance with Good Manufacturing Practice, Current Good Laboratory Practice, Current Good Documentation Practices, and FDA regulations such as 21 CFR Part 11 and Part 820

+ Perform system development tasks which include working with users and project engineers to define system needs, analyzing and designing system to meet user needs, translating user requirements to logic diagrams and program statements and conducting research in emerging technologies for the purposes of test and validation.

+ Perform Test Method Validation to finalize the testing methods.

+ Author technical documents (protocols, reports, standard operating procedures) to comply with regulatory requirements, Siemens quality procedures, and group functional needs

+ Ensure V&V process coverage by providing input, creating or revising V&V related procedures.The V&V Lead Engineer will also identify and implement V&V process efficiencies and establish best practices for our internal functional expertise.

+ Develop and establish effective Quality Control and associated Risk Management Plans

+ Review and test Diagnostics Communication Mechanism with newly developed testers

+ Provide technical support for very complex, highly critical programs and systems. Plan and coordinate tests, resolve production problems, identify opportunities to improve systems and architecture.

+ Maintain proficiency in programming languages, program development, testing and serve as an expert in area of responsibility.

+ Assist in the development, design/code, debug and implementation of electro-mechanical systems using LabVIEW architecture to test the instrument sub-systems.

+ Provide technical analysis and solutions to issues and technical direction.

+ Utilize technical expertise to manage multiple assignments, including large and critical projects to assure timely and cost-effect objectives delivery.

+ Schedule and prioritize work activities that accomplish the planned targets. Set priorities and provide reports to the management.

+ Author and manage test cases and bug through life cycle using Microsoft TFS and MTM software applications.

+ Works closely with all engineering disciplines including R&D Systems Engineering, Project Management, and Quality personnel to verify and validate products

+ Define and develop test systems in the lab. Ensure that all test systems and equipment are appropriate, maintained, and calibrated.

+ Work with project teams to create, review, and approve verification and validation deliverables

+ Review and analyze test data and record pass/fail results

+ Troubleshoot and perform root cause analysis for tester hardware and software defects

+ Work with electro-mechanical systems

+ Track and report on progress toward completion of verification and validation

+ Summarize the verification and validation performed, the data reviewed, and conclusions reached

+ Review test input requirements for completeness, correctness, clarity and testability

Research available open source tools and emerging technologies to provide innovative solutions to systems testing.

Conduct Test Method Validation, Gauge Repeatability and Reproducibility studies, Failure Mode and Effective Analysis, Software Hazard Analysis and ensure Risk Control Measures are implemented in design for system under development.

+ Participate in internal customer complaint activities and develop Correct Action and Preventive Action plan for already implemented systems

Perform application systems development tasks which include working with users to define system needs, analyzing and designing applications to meet user needs, design and review Technical/Functional documents and provide sign off, preparing flowcharts and diagrams to illustrate logical sequence, translating logic diagrams into program statements using LabVIEW Components, automate deployment & build process.

+ Identify and conduct training for V&V team members

Education/Experience Requirements:

+ B.S. degree in Computer Science, Engineering or other related discipline

+ 8+ years of experience in design verification or validation, emphasis on software driven hardware testing

+ IQ, OQ, PQ process experience

+ Experience creating verification and validation plans, protocols, and reports

+ High proficiency in requirements management, risk based testing approaches, defect tracking, and configuration control tools

+ Solid and practical understandingof test methodologies and test engineering best practices

+ Experience leading teams

+ Experience developing project plans and leading execution of same

+ Experience with product development per FDA design control and ISO 13485 desired

+ Experience working with electro-mechanical equipment and devices

+ Experience selecting test and measurement devices for suitable use

+ Demonstrated capability to solve technical problems

+ Knowledge of clinical chemistry medical devices or other equipment experience involving complex, multi-component systems

+ Programming experience (general)

+ Experience working with MS SQL databases

+ Experience with automation tools for testing applications

+ Familiar with engineering process improvement methodologies

+ Experience managing multiple tasks and priorities simultaneously and adapt to changes in program priorities

+ Demonstrated communication and interpersonal skills to conduct business with all levels of the organization

+ Technically communicate internally and with external clients

+ High proficiency in MS Excel, Word, PowerPoint, Project applications

+ Ability to exercise flexible work schedule to assure timely project completions

+ 5% 20% U.S. and international travel

+ Desired:

+ Master Degree in a related discipline

+ Test experience in medical or military products

+ Write scripts and develop other infrastructure for automated software test fixtures

+ SAP, Documentum, Sharepoint, Microsoft Team Foundation Server (TFS), Apache Subversion (SVN), Software Change Management Systems, Microsoft Test Manager (MTM), Microsoft Test Stand, Siemens Mi2i, Siemens Remote Services (SRS), Siemens T-REX, GTP Developer Tools and Interactive Electronic Documentation.

+ Labview experience

**Equal Employment Opportunity Statement**

Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

**EEO is the Law**

Applicants and employees are protected under Federal law from discrimination. To learn more, Click here at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

**Pay Transparency Non-Discrimination Provision**

Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf .


  • Engineering
  • Financial Services
  • Legal
  • Manufacturing / Production
  • Healthcare

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