Sr Principal Eng, Systems

Your Role

In the Senior Principal Engineer, Systems role, you will be responsible for Product Requirements management, Traceability, DHF structure & maintenance, Product Risk management, System integration, verification, and validation of medical devices. This position may own & perform relevant System Engineering activities for a family of devices in Acute therapies. Technically lead the team of system engineers towards realizing product development/enhancements over its lifecycle.

What you'll be doing

• 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. Perform impact assessment on the requirements on an ongoing basis for any proposed design/material/process change or an observation in the field/service, or manufacturing to determine the impact and need for any mitigation. 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
• Participate in identifying and planning tasks, activities, and resourcing needs related to systems engineering
• Facilitate an improved understanding of the interrelationship between Requirements, Risk, and Reliability
• Working knowledge of FMEAs and standards applicable to Systems Engineering
• 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

Required Skills

• 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.)

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

Vantive is committed to supporting the need for flexibility in the workplace.

We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

US Benefits at Vantive

• Health and well-being benefits including medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Financial and retirement benefits including the Aon Pooled Employer Plan (“Aon PEP”), Vantive’s 401(k) retirement savings plan, to help you prepare for your future
• 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 including commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits

Equal Employment Opportunity

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.

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Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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