Principal Systems Engineer
Role details
Job location
Tech stack
Job description
Translate customer needs, business objectives, and regulatory requirements into clear, testable system-level requirements Lead and execute risk management activities in accordance with ISO 14971 (Medical Device Risk Management Standard), including: Risk management planning Risk analysis and evaluation Risk control implementation and verification Decompose system-level requirements into subsystem and module-level requirements, ensuring traceability Plan and oversee reliability and robustness activities to ensure product performance over time Lead cross-functional teams in identifying and mitigating technical risks, resolving issues, and managing test defects Evaluate product and design changes holistically to ensure impacts are fully assessed across system, regulatory, and business dimensions Drive alignment across engineering, quality, and regulatory functions on system-level decisions and deliverables Support adherence to Baxter product development processes, documentation expectations, and regulatory requirements What You'll Bring
Requirements
Bachelor's degree in Mechanical, Electrical, Software Engineering, or a related technical discipline 5+ years of relevant engineering experience, preferably in medical devices or a regulated industry Strong working knowledge of: ISO 14971 (Application of Risk Management to Medical Devices) IEC 62304 (Medical Device Software Lifecycle Processes) IEC/TR 80002-1 (Guidance on Software Risk Management) Demonstrated ability to lead through influence in a cross-functional team environment Strong interpersonal and communication skills, with the ability to clearly convey complex technical concepts Ability to make sound decisions in the absence of complete information and navigate ambiguity effectively Strategic mindset with strong attention to detail and execution discipline Proven ability to manage multiple priorities and deliverables in parallel Strong problem-solving and critical-thinking skills Experience planning, estimating, and tracking technical work Solid understanding of both hardware and software development processes Demonstrated ability to write clear, concise, and verifiable requirements Adaptable and continuous improvement-oriented mindset, with a focus on simplifying complex processes 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.
Benefits & conditions
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-OM1 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: 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. 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 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 .