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Senior Staff Quality Engineer

Job Description

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Now’s our time to inspire the future of healthcare together.

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 ambitious professional, 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 of Design Controls & Risk Management to cross-functional teams responsible for new product development, and Design Changes to commercial IVD hardware products. As a Subject Matter Expert (SME), the individual must be able to lead Quality Management System improvement projects and Training efforts related to any of the elements within Design Controls.
  • Serves as Subject Matter Expert (SME) for application of Design Controls, while supporting product development and design change teams in accordance with regulatory expectations and company procedures
  • Leads effective deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of IVD Systems and related system software throughout the product lifecycle
  • Utilize quality engineering principles and problem-solving skills (risk analysis, problem solving methodologies, statistical techniques, etc.) to support the development and optimization of products/processes that are aligned with the overall Quality and Business vision.
  • Provides guidance, recommendations, and expectations related to Design Control, Risk Management, Quality Engineering (e.g., Quality System Regulation, EU IVDD/IVDR, ISO standards, etc.)
  • Ensures the comprehensive completion of design change, risk management, Design Verification, and Design Validation activities.
  • Support development and validation of control systems
  • Effectively utilizes Lean and Six Sigma methodologies as appropriate to achieve optimal results

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

  • 8 or more years relevant experience supporting the development and/or sustaining engineering associated with IVD hardware systems in a regulated environment with a core appreciation of FDA regulations and specifically the implementation and application of design controls.
  • Strong leadership skills and ability to influence cross functional teams to drive work scope to compliant and successful completion.
  • Self-starter, bias for action with ability to support projects through to completion. Good organization skills.
  • Cross technology and cross discipline collaboration skills
  • Understanding of Electromechanical Engineering, Software Development, Immunology, Clinical Chemistry and Hematology diagnostic system technologies is preferred.

Required skills to have for the success of this role

  • At a minimum, a BA/BS degree (in a Life Science, Engineering, or Physical Science preferred).
  • Expected working hours are standard business hours Monday to Friday when located in the US Eastern Time Zone
  • The incumbent is expected to be attached to one of the company’s sites located in Tarrytown NY., Flanders NJ., or Glasgow DE. but the position is expected to be primarily manageable from a Home Office.
  • This is an individual contributor role, providing specialized direction to professional counterparts on teams. Command of Leadership and role model qualities 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 healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.

If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.

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.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.

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