Product Risk Engineer – Cardiology image review and reporting software
Business Unit: Services
Requisition Number: 238969
Primary Location: United States-Michigan-Ann Arbor
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 10%
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.
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Join our team now at Siemens Healthineers as Product Risk Engineer
Siemens Medical Solutions, SYNGO R&D US Cardiology Team, has an opening for a Product Risk Engineer in the area of cardiology image reading and reporting software. The cardiology team delivers trend-setting cardiology software applications for medical image analysis and reporting used worldwide by cardiologists and other medical professionals. Our successful syngo Dynamics product line is in use at 4 of the top 5 cardiology hospitals in the US as ranked by the recent US News & world report. http://health.usnews.com/best-hospitals/rankings/cardiology-and-heart-surgery
syngo Dynamics operates as a regulated medical device with commitment to the highest quality and safety standards. Become part of a team committed to providing our clinicians with the highest quality software that supports patient-centric care.
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Product Risk Engineer, you will be responsible for:
· Conduct Risk Evaluation for product requirement and Potential Safety Complaints.
· Identification of Hazards which may cause harm to patients or operating personnel.
· Definition of risk mitigations in collaboration with Risk Management Team inclusive of Clinical and technical experts.
· Planning and execution of risk management activities with Risk Management team and project managers.
· Control of implementation of the risk mitigations and appropriate evidence
· Monitoring of risk controls
· Author of quality relevant documentation including Risk Analysis, Plan, and Report.
· Collection and systematic review of information about the product, including similarly defined products in the market.
· Chair Safety change control board meetings and participate in regular Change Control Board meetings.
· Participate in Usability Validation activity.
· Representation of risk management topics in audits, assessments and internal management meetings.
· Contribution to continuous improvement of Risk Management processes.
· The ideal candidate needs to demonstrate strong interpersonal skills, detail oriented and be an effective communicator – both verbal and written.
· Good working knowledge of ISO14971
· Exposure to ISO 13485
· Familiarity or experience with clinical workflows, usage of medical devices in hospital environments and Cyber Security.
· Ability to prioritize and manage multiple efforts in parallel.
· Experience as a team leader desired.
· Experience with international teams.
· Experience in DICOM, HL7 and medical imaging is a plus
· Minimum 7+ years of successful experience
BS degree in Computer Science, Engineering or a related field.