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.
At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
Join our team now at Siemens Healthineers as Compliance Engineer II.
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Compliance Engineer,
· You will support the development of engineering-level compliance requirements, component specifications, verification testing protocols and product certification testing in accordance with US FDA, EU Medical Devices Directives, CE, UL, etc.
· You will support the review and integration of new standards to ensure compliance with respective standards globally
· You will write documentation for medical device design projects and communicate with internal regulatory affairs personnel to support global clearances/approvals.
· You will support product labeling specifications, locations, and testing.
· You will support maintenance of technical files.
· You will review product and manufacturing changes for compliance with applicable regulations and verify testing reports for completeness and accuracy.
· You will support certifications and witness testing required for international product releases. (China, South Korea, Brazil, Russia, etc.)
· You will perform and oversee compliance testing to the standards
· You will collaborate with design teams to resolve compliance issues
This position may suit you best if you are looking to grow your career as a Compliance Engineer with world class complex medical products and would like to do develop your career with Healthineers. You will focus on current and next generation PET/CT, SPECT/CT and SPECT molecular imaging products (http://healthcare.siemens.com/molecular-imaging). The ideal candidate should have 1+ years of experience working with Notified Bodies, Certified Bodies and National Recognized Testing Laboratories in the development and creation of technical files for CE Self Certification. Working experience with compliance testing and certification to IEC 60601-1 collateral, particular and normative standards. Working knowledge and understanding of FDA QSR, EU MDD, CMDR, and CE Regulations. Understanding of ISO 13485 Quality System Requirements for advanced hardware and software medical systems.
This position will work across a cross-functional, multi-site organization with large and diverse teams, acting in a supporting role. The primary function of this role, will be to support the development and formal product certification testing, including country specific witness testing. A passion for delivering products that improve the outcomes of patient healthcare is essential for membership on our team.
Required skills to have for the success of this role
- Bachelor’s degree or greater in Electrical Engineering or related field
- 1+ years’ experience with compliance engineering including experience with medical devices
- 3+ years of engineering experience with complex products
- Strong interpersonal, written, and verbal communication skills
- Positive attitude, ability to work independently or in teams
- Ability to work in a fast-paced, time-critical dynamic environment
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.
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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