Principal Systems Engineer, Risk Management

Baxter
parental leave, paid time off, paid holidays, 401(k), employee discount
United States, Illinois, Round Lake
25212 Illinois 120 (Show on map)
Jan 08, 2025
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. Your Role at Baxter This is where you save and sustain lives. The research we do and the products we develop improve outcomes for patients around the world. As a Principal Engineer at Baxter, your work contributes directly to making a significant impact on others. It's challenging work-and you're not on your own. Our teams collaborate cross-functionally and lead by influence. Whether guiding a team through a project or managing direct reports, our research and development team is responsible for influencing others to achieve results. Our colleagues within our R&D organization desire to work on products that make a meaningful difference in others' lives. We are motivated by the power of teamwork and are natural leaders who are skilled at influencing others. Your Team As the Principal Systems Engineer for Risk Management, you will contribute to design concepts and research methodologies that meet current and future customer & business needs for a life-saving medical device. As a Principal Risk Engineer, you will collaborate with cross-functional stakeholders to design complex medical devices that meet customer needs and regulatory standards. This role includes application of ISO 14971 standard risk management principles, methods, and techniques to ensure products meet medical device design control best practices. You will also be responsible for the planning and execution of engineering assignments under the guidance of the Product Risk Management Owner. What you'll be doing: Embrace accountability for smaller deliverables that are a part of a larger project. Leads small sub-projects, as necessary, to accomplish objectives within area/role of responsibility. Analyze complex 'System of Systems' designs across engineering disciplines, documenting risks and ensuring risk controls and requirements are met. Perform Risk Assessments for issues occurring during new product development. Develop change control assessments, detailed impact plans, generating or reviewing risk documentation updates. Analyze data sources such as device utilization logs, medical literature and complaint data to estimate risk. Understand and contribute to resolution of competing constraints among inter-related functions (e.g., engineering, manufacturing, regulatory, marketing, medical) required to deliver products to market. Perform work with awareness of FDA, ISO and IEC design control procedures, regulations and standards within area of responsibility. What you'll bring: BS in Engineering and 5+ years related experience. Prior experience with product development lifecycle management (exploratory, new product development, or sustaining product support) including requirements management, risk management, V&V, and/or change management. Medical Device experience with Infusion Pumpsand Syringe Pumps is a plus. Effective written and verbal communication skills. Experience with other development and systems engineering tools preferred (e.g. Minitab, DOORS, ALM, etc.) Baxter 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 $104,000 to $143,000 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.#LI-ASR2 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. US 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 \| Baxter 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. EEO is the Law EEO is the law - Poster Supplement Pay Transparency Policy Reasonable Accommodations Baxter 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 Notice Baxter 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.