Sr Principal Eng, Systems

About the role

Vantive is a vital organ therapy company dedicated to extending lives and expanding possibilities for patients and care teams. We have a rich history in kidney care dating back 70 years and are now expanding our focus to transform vital organ therapies.

Responsibilities

• Product Requirements management, Traceability, DHF structure & maintenance
• Product Risk management
• System integration, verification, and validation of medical devices
• Technically lead the team of system engineers towards realizing product development/enhancements over its lifecycle
• Perform the activities associated with the Systems engineering of one or more products in various stages of the product lifecycle from new product development to post-market surveillance
• Gather inputs for Requirements from various sources such as, User needs, Regulatory Standards, Quality, Human factors, Manufacturing, Service, and so on.
• Develop the recommended mitigation strategy with a rationale.
• Expedite, manage, and coordinate interrelated systems activities across functions, within the constraints of human and financial resources and changing priorities
• Facilitate an improved understanding of the interrelationship between Requirements, Risk, and Reliability
• Create design concepts and research methodologies that best meet current and future customer & business needs for a product or process domain area
• Understand clinical and user needs and can apply to product realization. Create and maintains Design History File elements.
• Influence stakeholders and cross-functional team members within the project
• Teach and mentor others in life cycle management methodologies
• Initiates, develops and leads technical feasibility analysis for products or subsystems; translates customer/user needs to product needs
• Propose and drive solutions to complex technical problems that are ambiguous and diverse in scope
• Drive adherence to FDA, ISO and IEC design control procedures, regulations and standards
• Anticipate technical challenges and risk scenarios and prepares, leads, and executes mitigation strategies to ensure optimal results
• Perform as an independent reviewer in technical and design reviews

Requirements

• A Bachelor's Degree in Electrical, Mechanical, Biomedical, or a related engineering or science discipline
• 12 years or more of relevant experience
• Broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc.)

Qualifications

• Preferred Skills:
• Prior experience in Medical/Acute device domain
• Ability to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product
• A track record in electromechanical system development, preferably in medical devices or other highly regulated products such as military hardware
• Effective communication skills, both verbal and written
• Demonstrated strategic technical planning and thinking with ability to drive architecture/ platform/ technology deliverables into the product roadmap to ensure competitive differentiation

Skills

• Advanced Molding and Extrusion techniques
• Automation, reliability & smart manufacturing
• Bar coding, Printing, & Label Specifications
• Critical Systems
• Data Analysis & Analytics
• Digitalization & Systems Engineering
• First Principles Thinking
• In-depth Understanding of Operational Systems
• Instrumentation
• Laboratory Maintenance & Material Tracking
• Lean & six sigma process knowledge
• Machine Learning & Artificial Intelligence
• Manufacturing & Process Knowledge
• Manufacturing Process Knowledge
• Modeling & Simulation
• Operational Quality Assurance
• Packaging Assessments
• Packaging Design
• Packaging Regulatory Standards & Requirements
• Packaging Validation
• Packaging Verification Study Development & Testing Standards
• Process Automation
• Product / Project Management
• Product & Medical Packaging Materials / Equipment Knowledge

Benefits

Vantive offers comprehensive compensation and benefits packages including medical, dental and vision coverage, insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan (“Aon PEP”), Vantive’s 401(k) retirement savings plan, and Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.