Principal Engineer

Baxter International Inc

Round Lake, IL

JOB DETAILS
SALARY
$112,000–$154,000 Per Year
SKILLS
Analysis Skills, Biomedical Engineering, Bug Tracking/Defect Management, Change Control, Computer Science, Corporate Compliance, Cross-Functional, Decision Support, Documentation, Electrical Engineering, Electricity, Employee Benefits, Failure Mode and Effects Analysis (FMEA), Hazard Analysis, Healthcare, ISO (International Organization for Standardization), Industry Standards, Infusion Pumps, Internet Security, Interviewing Skills, Manufacturing, Market Tracking, Medical Equipment, Mentoring, Multitasking, Patient Safety, Philosophy, Problem Solving Skills, Product Design, Product Lifecycle, Product Reviews, Product Safety, Product Support, Regulations, Requirements Management, Retirement Plan, Risk, Risk Analysis, Risk Management, Risk Modeling, Stock Purchase Plans, Systems Engineering, Technical/Engineering Design, Traceability, Usability Engineering
LOCATION
Round Lake, IL
POSTED
9 days ago

This is where your work makes a difference.At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.Here, you will find more than just a job-you will find purpose and pride. Your role at BaxterThe Risk Engineer is responsible for leading and executing risk management activities for infusion pump systems through the product lifecycle. This role ensures patient and user safety by identifying hazards, assessing risks, and implementing effective mitigation strategies in compliance with corporate procedures and industry standards (e.g., ISO 14971) by working with engineering, quality, regulatory, clinical, manufacturing and service teams to integrate risk management into product design, development, and post-market activities in support of ongoing product safety.What you will be doing:Lead risk management activities in accordance with ISO 14971 and corporate procedures related to risk management plans, hazard analyses, FMEAs, fault tree analyses, and risk reportsIdentify hazards associated with infusion pumps, including mechanical, electrical, software, usability, and cybersecurity-related risksCollaborate with cross-functional teams during design and development to ensure risk controls are incorporated and verified and/or validatedEnsure traceability between hazards, hazardous situations, risk controls, and verification activitiesPerform robust risk impact assessments of issue records, change controls, complaint trends and NCR/SNCs and other scenarios using appropriate severity and probability models and ensure risks are reduced to acceptable levels or provide decision support to management or post-market monitoring.Update risk management files based on design changes and post-market information and ensure ongoing product safetyFacilitate risk reviews and risk management team meetingsTrain and mentor team members on risk management principles and toolsWhat you will bring:Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, Systems Engineering, Computer Science or related field)5+ years (senior-level) experience in medical device risk management or product developmentWorking knowledge of ISO 14971 and related standardsExperience with risk analysis tools (e.g., FMEA, FTA, hazard analysis), bug tracking tools, requirements management tools (e.g. DOORS) and traceability, and documentation.Excellent analytical, problem-solving, and communication skillsAbility to manage multiple priorities and project schedulesBaxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change. We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $112,000 to $154,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.#LI-OM1US Benefits at Baxter (except for Puerto Rico)This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental 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 include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer 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. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | BaxterEqual Employment OpportunityBaxter 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.Know Your Rights: Workplace Discrimination is IllegalReasonable AccommodationsBaxter 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.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

About the Company

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Baxter International Inc

Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations.
COMPANY SIZE
10,000 employees or more
INDUSTRY
Healthcare Services
FOUNDED
1931
WEBSITE
https://jobs.baxter.com/