Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.


Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.


Apply now for the position of Senior Compliance Engineer and you will be responsible for ensuring compliant global Siemens Molecular Imaging product offerings. This position is located at our Hoffman Estates, Illinois or Knoxville, TN location, and a substantive relocation package will be provided to out of state candidates.



This position may suit you best if you would like to focus your career on the development of current and next generation PET/CT, SPECT/CT and SPECT molecular imaging products ( http://healthcare.siemens.com/molecular-imaging ). 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.



Your role:


• Interpreting the regulatory standards applicable to large Medical Device and translate them to system requirements and verification.


• Defining compliance test procedure and processes for medical device.


• Developing engineering-level compliance requirements, component specifications, verification testing protocols and product certification testing in accordance with US FDA, EU Medical Devices Directives, CE, UL, IEC, etc.


• Interacting with external test laboratories and carrying out projects with them.


• Writing and releasing medical equipment device specifications and test reports.


• Supporting regulatory affairs personnel with global clearances/approvals.


• Defining product labeling specifications, locations, and verification testing.


• Reviewing product and manufacturing changes for compliance with applicable regulations and verify testing reports for completeness and accuracy.


• Performing and overseeing compliance testing to respective standards.


• Collaborating with design teams to resolve compliance related issues.


• Supporting review and integration of new standards to ensure global compliance with respective standards.



Your expertise:



• A degree in engineering or related field or previous compliance experience required.


• 5+ years' experience with compliance engineering including experience with medical devices.


• 5+ years of engineering experience with complex products ideally in a highly regulated environment.


• Experience with regulatory standards (ex, IEC, ISO, MITA, FDA, CISPR) applicable to large Medical Device.


• A degree or training in Legal Studies as part of study or experience, is a plus.


• 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.


• Part of standards development committee is a plus.


• Experience with development of FDA regulated products is a plus.


• Willing to travel up to 20%.


To find out more about our Molecular Imaging business, have a look at https://www.siemens-healthineers.com/en-us/molecular-imaging



Who we are:
We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.



How we work:
When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers


As an equal opportunity employer, we welcome applications from individuals with disabilities.


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