Principal Engineer – Risk and Reliability in Brooklyn Park, MN.

Baxter - Round Lake, IL (30+ days ago)3.9

About Baxter

Baxter 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. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Apply a solid understanding of theories/practices in Risk Management toward the development of new or enhanced products or processes. Support the advancement of Risk and Reliability competencies and execution across the Device Engineering organization.

Essential Duties and Responsibilities:
Plan, schedule, and lead project assignments using appropriate engineering techniques, processes, and methods with minimal guidance.
Identify and define risk and reliability related requirements from applicable product standards (collateral and particular).
Provide leadership and coaching to design teams in Risk process execution using relevant methodologies, tools, and techniques.
Lead and coach design teams in the development/maintenance of Risk planning and deliverables aligned with Baxter Global Risk Management procedures.
Collaborate with cross-functional resources (e.g. hardware, clinical, human factors, etc.) involved in Risk Management and Reliability process activities.
Support sustaining teams in investigation of Risk and Reliability issues.
Lead teams through credibility and influence.

Job Requirements:
Minimum 4-6 years of hands-on experience in Product Design, and fluent in full life-cycle product development methods/activities, preferably in a regulated industry.
Must possess engineering knowledge and experience in relevant electromechanical disciplines and design, preferably Medical Devices.
Working knowledge of Medical Device regulations (21CFR820, European MDD, Canadian Medical Device regulations, etc.).
Solid understanding and application of the standards related to Risk Management and Reliability: (e.g., ISO 13485, ISO 14971, IEC 60812, IEC 61025, IEC 62366, IEC 60601, IEEE-1633, etc.).
Demonstrated experience in creation of typical failure analysis deliverables (Hazards Analysis, FMEAs, FTAs, etc.).
Understanding and experience in performing root-cause analysis in investigations
Experience with reliability modeling, testing and prediction (life testing, HALT, HASS, ALT, Weibull analysis, warranty analysis, probabilistic reliability prediction, etc.).
Expertise and fluency in Excel, Minitab, Doors, and other Requirements Management & Risk tools.
Experience in appropriate use of statistical techniques required for developing reliability models, test methods, and risk deliverables.
Strong critical thinking skills.
Requires strong organization and polished communication skills (both written and oral), with the ability to interface with both technical and non-technical personnel throughout the organization.
Able to work independently or with a cross-functional team in a fast-paced environment.
Able to lead multiple projects and work across organization boundaries. Mechanical Engineering, Electrical Engineering, or related field and 5 - 8 year related experience.

A Career That Matters

Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter 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 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 and let us know the nature of your request along with your contact information.