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Senior Principal Engineer, Systems
4 weeks ago
Baxter is a leading global medical technology company that provides a broad portfolio of essential renal and hospital products, including home, acute, and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software, and services.
Role Summary:As a Senior Principal Engineer, Systems, you will be responsible for leading the development of medical devices, including product requirements management, traceability, design history file structure and maintenance, product risk management, system integration, verification, and validation. This role may involve owning and performing relevant system engineering activities for a family of devices in acute therapies.
Key Responsibilities:- Perform systems engineering activities across various stages of the product lifecycle, from new product development to post-market surveillance.
- Gather inputs for requirements from various sources, including standards, user needs, regulatory, quality, human factors, manufacturing, and service.
- 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.
- Work with cross-functional teams to drive solutions and product design realization from a systems perspective.
- Apply life cycle management principles across all phases of the product lifecycle.
- Develop and lead technical feasibility analysis for products or subsystems.
- Drive adherence to FDA, ISO, and IEC design control procedures, regulations, and standards.
- An engineering graduate in Electrical, Mechanical, Biomedical, or related engineering discipline with 12-18 years of experience.
- Demonstrated ability to work with technical leadership teams to implement product platform/subsystem multi-generation technology plans.
- Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines.
- A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products.
- Effective communication skills, both verbal and written.
- Demonstrated strategic technical planner and thinker with ability to drive architecture/platform/technology deliverables into the product roadmap.
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy, which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.
