Principal Engineer- Risk Management

Our client is an American multinational healthcare company. For over a century now, they have delivered on their commitment to saving and sustaining the lives of patients, working alongside clinicians and providers around the world. At the intersection of progress and purpose, they are redefining what it means to be a global medtech leader. Their forward-looking leadership team is a driving force in ensuring we meet the needs of all our stakeholders—every day and everywhere. They strive to create lasting value by empowering their patients, protecting the planet, and championing people and communities.

Role Description:

• Apply a solid understanding of System Engineering practices and theories/practices in Risk Management towards the development of new or enhanced Software products or processes.
• Support the advancement of Risk and Reliability competencies and execution across the Device Systems Software Engineering organization.

Responsibilities:

• Responsible for leading the activities associated with the Risk Management of products in various stages of the product lifecycle from new product development to post-market surveillance.
• Provides ongoing risk analysis and identification of required risk mitigations to ensure a safe, effective product.
• Responsible for identifying risks and helping define requirements and verification & validation testing to mitigate risk
• Drive completion of Risk Management activities towards design transfer and successful commercialization of new products.
• Provides leadership and subject matter expertise to product development teams to ensure Risk Management principles are applied throughout the development cycle.
• Creates and approves Design History File deliverables associated with Risk Management.
• Assesses and improves the Risk Management process.
• Facilitate an improved understanding of the interrelationship between Risk and Reliability.
• Expedite, manage, and coordinate interrelated Risk Management activities across functions, within the constraints of human and financial resources and changing priorities.
• Participate in identifying and planning tasks, activities, and resourcing needs related to Risk Management.
• Collaborates with Engineering, Manufacturing, and Service organizations in the development of design FMEA, Process FMEAs, and roll-up into Risk Management files. Working knowledge of FMEAs and standards applicable to Reliability Engineering (e.g. IEC 60812).
• Recognizes strategy, evaluates risks, recommends actions, and develops contingencies to address various scenarios. 
• Able to analyze risk/tradeoffs and make recommendations of the appropriate path forward.
• Motivates and successfully influences stakeholders and cross-functional team members within the project

Requirements:

• Graduate or Postgraduate in Electrical or Electronics or related Engineering and 10+ years of experience. 
• Prior experience in Risk Management, Reliability