Job Information

Siemens Senior Staff Quality Engineer in Newark, Delaware

Now’s our time to inspire the future of healthcaretogether.

Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.

Join our team now at Siemens Healthineers as Senior Staff Quality Engineer

This is a role well suited to an ambitiousprofessional, looking for the next step in their career. As a Senior Staff Quality Engineer , you will be responsible for :

  • This position is responsible to provide direction in the areas ofDesign Controls & Risk Management to cross-functional teams responsible fornew product development, and Design Changes to commercial IVD hardwareproducts. As a Subject Matter Expert (SME), the individual must be able to leadQuality Management System improvement projects and Training efforts related toany of the elements within Design Controls.

  • Serves as Subject Matter Expert (SME) for application of DesignControls, while supporting product development and design change teams inaccordance with regulatory expectations and company procedures

  • Leads effective deployment of Quality Engineering tools for theeffective and efficient development, transfer, and maintenance of IVD Systemsand related system software throughout the product lifecycle

  • Utilize quality engineering principles and problem-solving skills(risk analysis, problem solving methodologies, statistical techniques, etc.) tosupport the development and optimization of products/processes that are alignedwith the overall Quality and Business vision.

  • Provides guidance, recommendations, and expectations related toDesign Control, Risk Management, Quality Engineering (e.g., Quality SystemRegulation, EU IVDD/IVDR, ISO standards, etc.)

  • Ensures the comprehensive completion of design change, riskmanagement, Design Verification, and Design Validation activities.

  • Support development and validation of control systems

  • Effectively utilizes Lean and Six Sigma methodologies asappropriate to achieve optimal results

This position may suit you best if you are familiarwith what is below, and would like to do develop your career withHealthineers

  • 8or more years relevant experience supporting the development and/or sustainingengineering associated with IVD hardware systems in a regulated environmentwith a core appreciation of FDA regulations and specifically the implementationand application of design controls.

  • Strongleadership skills and ability to influence cross functional teams to drive workscope to compliant and successful completion.

  • Self-starter,bias for action with ability to support projects through to completion. Goodorganization skills.

  • Crosstechnology and cross discipline collaboration skills

  • Understandingof Electromechanical Engineering, Software Development, Immunology, ClinicalChemistry and Hematology diagnostic system technologies is preferred.

Required skills to have for thesuccess of this role

  • Ata minimum, a BA/BS degree (in a Life Science, Engineering, or Physical Sciencepreferred).

  • Expectedworking hours are standard business hours Monday to Friday when located in theUS Eastern Time Zone

  • Theincumbent is expected to be attached to one of the company’s sites located inTarrytown NY., Flanders NJ., or Glasgow DE. but the position is expected to beprimarily manageable from a Home Office.

  • Thisis an individual contributor role, providing specialized direction toprofessional counterparts on teams. Command of Leadership and role modelqualities is a must.

Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full vaccination for COVID-19 for our U.S. employees, contractors, and business partners, where local conditions allow, who:

1) Are customer-facing (e.g., those required to visit a customer/business partner site or interact in-person with customers at any conference or meeting) OR

2) Come on-site, whether regularly or occasionally, at any Siemens Healthineers location.

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

If you want to join us in transforming the way healthcareis delivered, visit our career site at .

If you wish to find out more about the specific before applying, please visit: .

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.

Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full vaccination for all new hires by their start date. (Note: Accommodations may be requested for certain medical or religious reasons).

Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Experienced Professional

Job Type: Full-time

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 unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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