Lead Systems/Quality Engineer

About CoraVie Medical

CoraVie Medical is a seed-stage medical device company building a minimally invasive, circadian blood pressure monitoring (CBPM) system for patients with uncontrolled hypertension. This CBPM system will be the first of its kind, focused on the unmet needs of physicians, and patients. Our vision is to prevent cardiovascular disease worldwide by enabling clinicians, patients, and caregivers with empowering insights so patients can live longer, happier lives.

CoraVie’s technology and approach to blood pressure are bold and disruptive.We are working with the latest technological advances and building a unique product that has applicability across multiple future markets. We are now actively searching for a Lead Systems Engineer that can accelerate our execution to milestones to deliver a winning product.

Responsibilities of the Lead Systems / Quality Engineer

The Lead Systems/Quality Engineer will be responsible for leading the design and development of a novel highly integrated system platform from conception to commercialization.This includes translation of customer needs and performance requirements into a total system solution aligns with technical, quality, regulatory, schedule, and cost constraints to deliverregulatory clearance of CoraVie Medical’s first-generation product. The Lead Systems/Quality Engineer will direct other engineers and outsourced vendors on needs to be addressed, prioritization and trade-offs, and architecture of solution that streamlines product development to meet deliverables on time and budget.

Job Responsibilities

• Lead discussions and provide guidance to external current and potential future vendors / partners, interdisciplinary teams of SW/Electrical/Mechanical professionals.
• Support system verification execution and test development.
• Conceptualize and author product specifications, architectural and high-level design, functional specifications.
• Assess and develop testing strategy, and integration use case scenarios.
• Provide input for submissions to regulatory bodies and governmental agencies.
• Manage changes to interfaces during development and throughout the product lifecycle.
• Develop design history file (DHF) and ensure compliance to quality metrics, defining the interface requirements between systems and maintaining traceability of requirements.
• Perform systems engineering (Use Case development, requirements decomposition, activity diagrams, et. al) activities supporting product development milestones.
• Develop complex systems, including embedded systems, sensors, and algorithms, with cross-functional teams of hardware engineers, software engineers, and research scientists.
• Provide technical direction to team and outsourced vendors to maintain integrity of system solution that aligns with customer, quality, and regulatory requirements.
• Communicate project and technical status regularly, keeping leadership informed of progress and issues, and escalating as appropriate.

Education/ Work Experience

• Experience creating and maintaining Design History Files.
• Experience managing outsourced vendors to a task and deliverable.
• Extensive experience of contemporary design control and risk management practices, ISO, FDA design control standards and requirements.
• Demonstrated experience in creating solutions that seamlessly fit into customer workflows.
• Demonstrated experience generating technical documentation such as requirements, specifications, engineering reports, plans & procedures.
• Engineering or science degree required.
• Experience in embedded devices design, development, verification, and documentation
• Experience coordinating technology designs with architectural requirements and constraints.
• Experience developing regulated medical device systems that strictly adhere to design controls and quality management system requirements.
• 10+ years working with active implantable medical devices or directly translatable work experience.

Skills

• Familiarity with multiple, diverse technical integrations, technologies, and processing environments
• Ability to work effectively in an environment of ambiguity and undefined resources.
• Consistent clear communication across all levels of the organization.
• Proficiency withrequirements management and system modeling tools.
• Excellent prioritization and project management skills.
• Self-motivated and results oriented with focused urgency, prioritization skills and ability to recognize/escalate issues appropriately.
• Knowledge of Matlab, C, Python, and/or Javascript.
• Lean Project Management, Six Sigma.

CoraVie Values

CoraVie Medical has established values and behaviors that are foundational to what we do and how we do it.We value and behave with respect, integrity, inclusion, customer-focus, and teamwork. We are problem solvers without an ego.Our goal is to make our customers look good, both internal and external.As leaders, we take responsibility for failures and celebrate those that enable success. We make sure all have a voice, because by proactively including all we will deliver the best innovation and solve the most difficult problems.