Head of Requirements Engineering & Risk Management

Head of Requirements Engineering & Risk Management, Point of Care

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.

Join our team now at Siemens Healthineers as a Head of Requirements Engineering & Risk Management. This role is well-suited to an ambitious professional looking for the next step in your career. As the Head of Requirements Engineering & Risk Management you will be responsible for:

• Growing & leading a team of requirements engineering and risk management staff in the Point of Care business unit for Siemens Healthineers.
• Ensuring staff skills, practices, processes, and tools are adequate for efficient & effective functioning of team supporting new product development and on-market products.
• Ensuring the team is proficient in system definition - user needs, extracting system level requirements from user needs, business needs and decomposition to subsystem requirements.

·       Ensuring the team is proficient in translating the product vision and scope into clearly articulated system & sub-system level requirements collaborating System Architects, Product Managers, Product Owners, and other applicable functional roles.

• Ensuring the team is proficient in requirements elicitation, elaboration, categorization, management, traceability, support risk analysis, technical reviews, and V&V efforts.
• Ensuring the team is proficient in assisting product management in product planning through requirements development, analysis and managing new product features and updates.
• Establishing global standards and processes for managing risks, in line with industry expectations and regulations. Maintain Risk Management deliverables to ensure continued acceptability of products based on post market feedback.
• Ensuring that risk management documentation is accurate, complete, and readily accessible for audits and inspections.
• Supporting sites through audits and inspections including audit preparation activities, addressing questions and requests specific to the Risk Management Program.
• Leading and supporting cross-functional activities and teams in maintaining, controlling, and improving RM processes within their designated area.
• Performance management of individuals in the team, manage resource allocations, project demands and budgets, optimal allocation of resources for coverage of work and objectives.

This position may suit you best if you are proficient with the below skills and would like to develop your career with Healthineers:

• Deep knowledge of Systems Engineering principles and best practices. Experienced in requirements management, risk management, and system architecture.
• Demonstrated ability to collaborate and contribute to cross functional product development teams.
• Develop collaborative working relationships with a range of functions including, but not limited to R&D, Marketing, Engineering, Manufacturing, Supply Chain functions.
• Apply persuasion to change the thinking of and/or gain acceptance from various stakeholders, cross-functional teams and drive decision making while maintaining an effective working relationship.
• Solid understanding of structured product development (requirements-driven engineering, documentation, verification, etc.). Proficient in Tools & Processes related to requirements, risk & systems engineering.
• Proficient and experienced in developing complex electromechanical medical devices.
• Highly motivated self-starter able to achieve results with minimal oversight. Excellent written and verbal communication skills, strong creative, analytical, and problem-solving, technical judgement, leadership, and interpersonal skills.
• Able to communicate effectively at all levels of a matrixed organization, as well as coach and present new ideas.
• Broad project management skills and the ability to seamlessly switch between big picture thinking and product-level details.

Experience and requirements for success in this role:

• Degree in Engineering, Science or Systems Engineering or relevant experience in medical device industry.
• Demonstrated experience in building and leading teams.
• Leadership experiences and skills, including the ability to collaborate, influence, coach, and guide colleagues to achieve meaningful results and make a business impact.
• Proficient in tools such as DOORS, Teamcenter or similar.
• In-depth knowledge of FDA, ISO, IVDD and IVDR regulations.
• Proficient with Quality Risk Management and/or medical device risk management experience, risk analysis techniques (e.g., FMEA, Use-Related Risk Assessment, Hazard Analysis).
• Experience with systems engineering (e.g., requirements, verification/validation, design and test traceability, risk management)
• Experience with MBSE concepts and tools (MagicDraw) is desired.

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 specific 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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