Senior Principal Engineer, Global Product Quality Cybersecurity
Job Description
Vantive, a distinguished leader in vital organ therapy with a 70-year legacy in kidney care, is seeking a Senior Principal Engineer for Global Product Quality Cybersecurity. This remote position represents a unique opportunity to join a company that's revolutionizing healthcare technology while maintaining the highest standards of security and compliance.
The role combines technical leadership in cybersecurity with quality assurance in the medical device industry. You'll be responsible for ensuring that all product development processes meet FDA and other regulatory standards, with a particular focus on cybersecurity. Your expertise will be crucial in conducting risk assessments, managing vulnerabilities, and establishing robust security protocols that protect vital medical technologies.
As a senior technical expert, you'll collaborate with cross-functional teams, provide guidance on FDA design control requirements, and foster a culture of security-conscious development. The position requires a deep understanding of both cybersecurity principles and medical device regulations, making it perfect for someone who wants to make a meaningful impact in healthcare technology.
The ideal candidate brings at least 5 years of FDA design control experience, strong knowledge of cybersecurity frameworks like NIST, and excellent leadership skills. You'll be joining a company that's committed to extending lives and expanding possibilities for patients and care teams worldwide, making this role both technically challenging and deeply meaningful.
Working at Vantive offers the opportunity to be part of a transformative journey in healthcare technology, while contributing to the safety and security of medical devices that directly impact patient care. The company's focus on innovation, combined with its commitment to quality and security, makes this an excellent opportunity for a cybersecurity professional looking to make a difference in healthcare technology.
Responsibilities For Senior Principal Engineer, Global Product Quality Cybersecurity
- Ensure product development processes adhere to FDA and other regulatory standards
- Conduct cybersecurity risk assessments throughout product lifecycle
- Collaborate with teams to establish quality assurance processes
- Provide guidance on FDA design control requirements and cybersecurity principles
- Serve as product security technical expert within Quality organization
- Interface with regulators during regulatory inspections
- Manage quality security risk assessments of supplier's products
- Lead continuous improvement projects
- Coach and train on product cybersecurity regulations and procedures
Requirements For Senior Principal Engineer, Global Product Quality Cybersecurity
- Bachelor's degree in engineering, computer science, or related field (advanced degree preferred)
- Minimum 5 years of experience in FDA design control within medical device or cybersecurity industry
- Strong knowledge of cybersecurity principles, standards, and best practices
- Experience with risk management methodologies
- Ability to mentor employees
- Good communication and leadership skills
- Knowledge of NIST Framework, FDA Cybersecurity guidance, MDCG
- Experience with SOUP/OTS implementation and vulnerability monitoring
- Experience with threat modeling (STRIDE)
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