Principal Systems Engineer

Job Summary

Vantive is seeking a Principal System Engineer to support the overall technical direction of Acute Therapies products. This role involves driving various portions of the product development cycle from feasibility through lifecycle management, including design concepts, product requirements, system integration, verification, and validation of medical devices.

Responsibilities

• Perform 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
• Understand clinical and user needs and apply them to product realization
• Capture inputs for requirements from various sources such as user needs, regulatory standards, human factors, quality, manufacturing, service, etc.
• Drive solutions and product design realization from a systems perspective
• Create and maintain design history file elements
• Facilitate an improved understanding of the interrelationship between requirements, risk and reliability
• Anticipate technical challenges and risk scenarios and prepare, lead, and execute mitigation strategies to ensure optimal results
• Resolve systems-related technical issues by applying problem-solving tools such as cause-and-effect diagrams, Pareto charts, etc.
• Propose and drive solutions to technical problems that are ambiguous and diverse in scope
• Propose recommended mitigations with rationale
• Influence stakeholders and cross-functional team members within the project
• Drive adherence to FDA, ISO and IEC design control procedures, regulations and standards
• Use various software tools and programs to complete the above responsibilities
• Teach and mentor others in life cycle management methodologies

Requirements

• Bachelor’s degree and 5+ years or more of relevant experience, or Master’s degree and 4+ years or more of relevant experience, with a degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline
• Prior experience in medical devices, preferably for ICU or kidney care domains
• Sound knowledge of systems engineering and related areas such as electro-mechanical and software engineering
• Track record in electro-mechanical system development, preferably in medical devices or other regulated products such as aerospace, automobile, or military
• Prior experience with internet-connected, software-enabled devices and/or cyber security
• Working knowledge of system modeling language (SysML or UML) and requirement management tools
• Familiar with statistical methods/tools for design and verification, e.g. DOE, sample size
• Excellent interpersonal, communication, and influencing skills
• Ability to work independently
• Ability to manage simultaneously several projects and shift priority according to needs
• Demonstrated strong analytical and problem-solving skills
• Advanced Molding and Extrusion techniques (Learning / Doing (1)), Automation, reliability & smart manufacturing (Applying / Overseeing (2)), Critical Systems (Applying / Overseeing (2)), Data Analysis & Analytics (Applying / Overseeing (2)), Digitalization & Systems Engineering (Applying / Overseeing (2)), First Principles Thinking (Applying / Overseeing (2)), Instrumentation (Leading / Driving (4)), Lean & six sigma process knowledge (Applying / Overseeing (2)), Machine Learning & Artificial Intelligence (Not Applicable (0)), Manufacturing & Process Knowledge (Applying / Overseeing (2)), Manufacturing Process Knowledge (Leading / Driving (4)), Modeling & Simulation (Leading / Driving (4)), Operational Quality Assurance (Applying / Overseeing (2)), Process Automation (Applying / Overseeing (2)), Product / Project Management (Applying / Overseeing (2)), Product Knowledge (Leading / Driving (4)), Quality Management Systems (Leading / Driving (4)), Regulatory Compliance (Leading / Driving (4)), Smart Operations / Industry 4.0 (Learning / Doing (1)), Software Integration (API, Data Pipelines) (Not Applicable (0)), Software Process Management (Leading / Driving (4)), Sterilization methods (Leading / Driving (4)), Systems Validation (Leading / Driving (4))

Qualifications

• Ability to work independently
• Ability to manage simultaneously several projects and shift priority according to needs
• Demonstrated strong analytical and problem-solving skills
• Advanced Molding and Extrusion techniques (Learning / Doing (1)), Automation, reliability & smart manufacturing (Applying / Overseeing (2)), Critical Systems (Applying / Overseeing (2)), Data Analysis & Analytics (Applying / Overseeing (2)), Digitalization & Systems Engineering (Applying / Overseeing (2)), First Principles Thinking (Applying / Overseeing (2)), Instrumentation (Leading / Driving (4)), Lean & six sigma process knowledge (Applying / Overseeing (2)), Machine Learning & Artificial Intelligence (Not Applicable (0)), Manufacturing & Process Knowledge (Applying / Overseeing (2)), Manufacturing Process Knowledge (Leading / Driving (4)), Modeling & Simulation (Leading / Driving (4)), Operational Quality Assurance (Applying / Overseeing (2)), Process Automation (Applying / Overseeing (2)), Product / Project Management (Applying / Overseeing (2)), Product Knowledge (Leading / Driving (4)), Quality Management Systems (Leading / Driving (4)), Regulatory Compliance (Leading / Driving (4)), Smart Operations / Industry 4.0 (Learning / Doing (1)), Software Integration (API, Data Pipelines) (Not Applicable (0)), Software Process Management (Leading / Driving (4)), Sterilization methods (Leading / Driving (4)), Systems Validation (Leading / Driving (4))

Benefits

• 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, 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

Pay

The estimated base salary for this position is $108,000 to $148,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors.

Schedule

Vantive offers a flexible workplace policy which includes a minimum of 3 days a week onsite.

Benefits

Vantive offers a variety of benefits including:

• Medical, dental, and vision coverage
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• The Aon Pooled Employer Plan (“Aon PEP”) for retirement savings
• Flexible Spending Accounts
• Education assistance programs
• 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
• Childcare benefits

EEO Statement

Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.