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Principal Engineer Systems

Req #: JR - 067172 Location Medolla, Emilia-Romagna, Italy Job Category: Research and Development Date Posted: 04/21/2022

Overview

This is where new knowledge is discovered. Baxter’s Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives.

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Research and Development team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Courage
  • Action Oriented
  • Collaborates
  • Cultivates Innovation
  • Manages Ambiguity
  • Drives Results

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Principal Engineer Systems

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary

Principal Engineer, systems act as interface between Bangalore R&D (BRD) Sustaining teams and Medolla Operations, concerning manufacturing and design lifecycle of Acute therapy devices in Medolla as far as Sustaining Products Organization (SPO) activities are concerned. Uses state-of-the-art techniques to inspire success in cross-functional teams working collaboratively to achieve Acute therapy device designs that meet customer needs. Actively works with technical team in resolving difficult problems in a collaborative environment. Applies standard risk management principles, methods, and techniques to ensure products meet medical device design control best practices. Plans, investigates, supports, executes, and functionally directs engineering assignments, which require independent judgment.

Job Responsibilities:

  • Engaged and influential member of the team as the systems product engineer of moderate to high complexity devices.
  • Analyzes and approves complex designs across engineering disciplines, documenting risks and ensuring risk controls and requirements are met.
  • Ensures inclusion of inputs into product and technical design reviews from all cross functional stakeholders.
  • Anticipates technical challenges and risk scenarios and prepares, manages, and executes mitigation strategies to ensure optimal results.
  • Establishes, maintains, and actively develops associations with cross functional business partners and/or functional peers across Baxter.
  • Utilizes creative thinking and teamwork to resolve conflicts.
  • Makes proficient and disciplined critical decisions and systems deliverables (e.g. program milestones, technical design reviews).
  • Embraces team and management decisions while also raising issues to appropriate level.
  • Works with Project Management to create and manage schedules for systems and sub-systems.
  • Designs to meet regulatory requirements as determined by FDA, ISO, and IEC standards.

Major Responsibility:

  • Coordinate efforts of cross functional teams in Medolla such as operations, manufacturing, suppliers’ quality, logistics for shipping and act as an interface to BRD team.
  • Support SPO/sustenance activity for products during product design lifecycle (i.e., Change Controls) and with initial investigation for defects raised from manufacturing, supplier, service, and field.
  • Ensures cross-functional review, discussion, and debate of input; identifies, prepares, and collaborate with appropriate stakeholders within functional, program and/or project team to make decisions.
  • Supports relationships with local suppliers and test facility.
  • Local logistical support for suppliers’ sampling and shipping to BRD/Brooklyn Park (BP).
  • Provides leadership and subject matter expertise to SPO teams to ensure Risk Management principles are applied throughout development cycle.
  • Understands and contributes to resolution of competing constraints among inter-related functions (e.g. engineering, manufacturing, regulatory, marketing) required to deliver products to market.
  • Knowledge of the regulatory environment for Design, Develop and Manufacture of Medical products.
  • Collaborate to define protocols and conduct the necessary testing required to verify/validate the quality, safety and performance of the design(s).
  • Support BRD and BP during audits (R&D), identifying and communicating with local supplier and working with local test facility.

Qualifications:

  • B.S. or M.S in Engineering (Mechanical, Electrical, or Software) with 10 years industrial experience.
  • Preferred: Minimum of 5 years of relevant experience in medical device industry.
  • Demonstrated knowledge of engineering disciplines and solid knowledge of related disciplines, Systems, Electro/Mechanical, Fluid Mechanics, Materials Science, etc.
  • Experience applying ISO 14971 to the design and development of complex, safety critical medical devices
  • Must have good working knowledge of regulations and standards affecting medical devices and have experience with products under design controls, documentation controls, risk management, and validation.
  • Cross-functional team collaboration experience, including technical and non-technical work.
  • Success in delivering results on technical challenges including investigative and problem-solving skills
  • Has organized and presented technical and project overviews without assistance.

Requirements:

  • Excellent English verbal and written communication skills.
  • Solid computer skills: email, documentation and collaboration tools: e.g. WebEx, Teams, Microsoft Office products, ERP tools, etc.
  • Self-directed, resourceful, and able to work on multiple projects and priorities.
  • Strong organization, attention to detail, and documentation skills.
  • Preferred hands-on lab skills, and prototype fabrication skills.
  • Analytical, detail-oriented, thorough, and accurate. Open to accepting critiques and striving for continuous improvement in every task
  • A strong collaborator able to work independently and in a team
  • Ready to handle a broad range of tasks with multiple priorities
  • Focused on consistency, using style guides, branding guidelines, and company procedures to produce documentation
  • Clear and effective communication (written and oral) and presentation skills.
  • A proven track record of effectiveness in a fast-paced environment.
  • Proven ability to create results within budget, timeline, and product/project deliverables.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

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067172

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Reagan, Senior Research Scientist in the United States

"For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference."

Reagan

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

"I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world."

Karthik

Meet Amitha, Research Associate in India

"Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter."

Amitha

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Reagan

Meet Reagan, Senior Research Scientist in the United States

"For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference."

Karthik

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

"I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world."

Amitha

Meet Amitha, Research Associate in India

"Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter."

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