Siemens Healthineers - Digital Services will empower healthcare providers to transform towards value-based care, ultimately leading towards personalized medicine.
SHS DC IND DS is a key partner for Digital Services in developing digital products involving topics like Artificial Intelligence, Machine Learning.
What are my responsibilities?
The Product Risk Manager in Digital Services is responsible for (but not limited to) :
• Identification and evaluation of risks which may occur to patients, operating personal or the device itself
• Documentation of risk evaluation results
• Definition of risk mitigation in collaboration with Product Management and Architects
• Planning and execution of risk management activities with Project managers
• Control of implementation of the risk mitigations and appropriate evidence as required by Product RIsk Management process
• Responsible for authoring documents like: Risk Analysis, Risk Management Plan, Risk Management Report
• Mandatory Reviewer of various process- and product documents
• Collection and systematic review of information about the product (incl. similar products) in the production and the post-production phase
• Representation of the risk management in Audits, Assessments, …
• Contribution to continuous improvement of Risk Management Process
Regulatory Affairs & Quality Management & Designated Complaint Unit (DCU); Project and Product Management; Project Steering Group (PSG); SW Development/Test; Technical Documentation; Supplier Management
Risk Manager of other business units; Customer; Supplier; Auditors and assessors
Qualification: B.E. / B.Tech / MCA/ M. Tech/ MSc (Computer Science)
Knowledge and Experience:
• 7 – 10 years of experience in Software Development / R&D activities
• Advanced knowledge about the medical device and its operation/use in customer environment
• Experience in working with products involving Artificial Intelligence/Machine Learning
• Experience in Quality management and/or Regulatory Affairs recommended
• Hands-on experience (participation) in risk analysis activities
• Exposure to TFS is preferred
• Sound knowledge of software engineering processes is mandatory
General/Soft Skill requirements:
• Ability to learn and work independently
• Strong Analytical and Problem Solving Skills
• Able to make decisions; Result oriented
• Assertiveness and excellent communication skills
• Experience of working in geographically distributed teams.