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.
Join our team now at Siemens Healthineers as a Staff PLM Software Process Professional and be part of the team that delivers state of the art PET, SPECT and Clinical Applications medical imaging software. This position is located at Hoffman Estates, IL (primary location) but it can alternatively be located in Knoxville, TN and relocation will be provided to out-of-state candidates for either state.
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Staff PLM Software Process Professional, you will be responsible for activities such as, transforming SW best practices into process improvement changes, reporting project quality metrics to executive staff, ensuring alignment of SW development to Quality Regulations from Siemens Healthineers. You will be working in collaboration with a cross-functional and international team involved in the development of PET, SPECT and Clinical Applications software products.
Specific Job Responsibilities
- Research and develop best practice for Software Development within the Medical Device industry, individually and in collaboration with the broader development team.
- Consolidate evolving best practice into process changes in collaboration with process owners and cross-functional stakeholders.
- Organize and drive roll-out of process/practice changes across the organization including allocation of training based on roles and responsibilities.
- Follow-up on effectiveness of changes with impacted teams and stakeholders.
- Manage and address official change requests to processes including Corrective or Preventative actions (CAPAs) due to insufficient processes.
- Set up and maintain reporting structure for project quality metrics, including reporting at Executive Quality Management Reviews
- Align practices with other business lines to support "inner source", "open-source software" and "unified process/tooling" initiatives.
- Support the identification of "Off the Shelf" and Quality System Software used by the organization and establish a framework to validate for intended use.
- Represent the software department at internal and external audits.
- Ensure MI processes align with Quality Regulations from Siemens Healthineers (including Security, Data Protection)
- Ensure software processes adhere to relevant medical device standards (e.g., ISO62366, ISO62304, IEC82304) (FDA, cGMP, MDD) and relevant stakeholders are aware of impacting changes
This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers
· You have a Bachelor’s degree in computer science or related fields and preferably 5+ years of experience in the Medical Device Process or Quality related field
· You have experience in modern SW development processes like Agile/SAFe, Lean, Iterative development methodologies
· You have demonstrated ability to drive process related improvements across an organization
· You are familiar with relevant medical device standards (e.g., ISO62366, ISO62304, IEC 82304) (FDA, cGMP, MDD)
· You have excellent analytical and problem-solving skills
· You have a demonstrated ability to work successfully in international teams
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 specifics 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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