Senior Compliance Engineer
Siemens Medical Solutions USA, Inc.

Job Info

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Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as a Senior Compliance Engineer to help us ensure compliant global Siemens Molecular Imaging product offerings. This position is located at our Hoffman Estates, Illinois or Knoxville, TN location.

Our global team : We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what's possible in healthcare to help improve people's lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

Our culture : We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what's possible, to improve people's lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers .

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

• 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.

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



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 ). The ideal candidate should have 5+ 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. Experience is working for or with ISO/IEC 17025 accredited test labs.

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

• Candidate will be required to have a degree in engineering or related experience.

• 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.

• 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.

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

• Part of standards development committee is a plus.

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

• Willing to travel up to 20%.

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.

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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 Siemens Healthineers 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.

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