Back

Catheter Quality Leader

Job Description

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 Catheter Quality Leader

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Catheter Quality Leader, you will be responsible for:
  • You will be leading a matrixed team of global quality, regulatory, engineering and manufacturing professionals in alignment with FDA, EU MDR and other applicable regulations and standards for Ultrasound Intra-Cardiac (ICE) Catheters.
  • Work closely with RA partners in providing global regulatory requirements guidance, review and approval process involving device registrations, promotional materials, labeling, product and process changes, documentation etc. to name a few.
  • You will provide Quality and Regulatory compliance guidance to Catheter business leaders and cross functional team members throughout product development lifecycle as they execute on product and business imperatives.
  • You will be responsible for executing design quality engineering activities for ICE Catheter programs (e.g. review and approval of requirements, design verification, validation methods and protocols etc.)
  • Work closely with engineering and manufacturing partners to establish robust product development and manufacturing processes/practices/tools, process validations (IQ/OQ/PQ) and related measurements and metrics (KPIs)
  • You will drive and participate in the development of unique design, manufacturing, distribution etc. processes to strengthen the quality and profitability of the Catheter business. 
  • You will identify and drive continuous improvement opportunities in product lifecycle process compliance and product quality efforts (e.g. Lean, Agile, KPIs, Value Stream Mapping, Structured Problem Solving etc.)
  • Work closely with QA partners to drive and implement QS activities such as training, risk management, inspections & audits, defects and complaint handling, CAPA to name a few
This position may suit you best if you are familiar with what is below, and are seeking to develop your career as an organizational leader: 
  • Experience in class III medical device, preferably catheters or similar high-risk devices is a strong plus.
  • Strong Product Design and Development experience. Working knowledge of risk management, hazards analysis, corrections and recalls, statistical analysis techniques is a plus.
  • Willing to travel up to 10% and schedule flexibility to accommodate global locations
  • Good presentation skills when communicating with senior management 
Required skills to have for the success of this role:
  • Bachelor of Science in Engineering, Systems Engineering or related field.
  • 5+ years of quality/regulatory experience in medical devices, familiarity with global medical device regulations.
  • Influential Leader and Clear Communicator, Self-driven Cross-Functional abilities in a global environment is a must
  • Expert knowledge of Design Quality Engineering and experience applying ISO 14971/24971 standards to a complex product, and detailed working knowledge of 21 CFR 820, ISO 13485, IEC 60601-1, ISO 10555 standards 
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. 

*LI-WC1

Organization: Siemens Healthineers

Company: Siemens Medical Solutions USA, 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.

California Privacy Notice
California residents have the right to receive additional notices about their personal information. To learn more, click here.

Can't find what you are looking for?

Let's stay connected

Can't find what you are looking for?