Principal Systems Engineer

Baxter

  • Bellevue, WA
  • $104,000-143,000 per year
  • Permanent
  • Full-time
  • 16 days ago
This is where you save and sustain livesAt 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 teamBaxter’s goal is to empower clinicians and health systems with the tools to make a difference in patients and clinician’s lives. While everyone at Baxter has a shared passion for our mission, the R&D teams play a meaningful role in our ability to save and sustain lives. Do you want to use your systems engineering skills to make a difference in the world of Cardiology? Bardy Diagnostics is an exciting, high-growth organization within Baxter with outstanding and compelling products looking for the right Principal Systems Engineer to help us achieve our mission. The ideal candidate will have a broad technical background spanning hardware, software, mobile, and cloud technologies with a deep understanding of medical device regulations and best practices.Your Role at BaxterBaxter is currently seeking a Principal Systems Engineer to join the R&D team at our Bellevue office. In this role, you will be responsible for driving the development and integration of complex, end-to-end medical device systems that involve wearable devices with sensors, mobile applications, software algorithms, cloud software applications, user portals and gateways, and data pipelines. You will apply systems engineering principles throughout the entire product lifecycle, from concept and design to verification, validation, and product launch.What you'll be doing
  • Lead the definition and capture of system architecture, requirements, and specifications for end-to-end medical device systems, ensuring seamless integration and interoperability between wearable devices, mobile applications, software algorithms, cloud software applications, and user portals.
  • Define, document, and manage system requirements across all components of the end-to-end system, ensuring traceability and alignment with regulatory standards.
  • Oversee comprehensive test plans and protocols to verify and validate system performance, safety, and security across the entire end-to-end ecosystem.
  • Evaluate system integration points and lead the team in integration planning and testing.
  • Develop comprehensive system models, risk analyses, and mitigation strategies, addressing the unique challenges of each component in the end-to-end system.
  • Work with development engineers to analyze system performance, reliability, and data integrity across the entire data pipeline, from wearable device data collection to cloud storage and processing.
  • Act as a subject matter expert for project teams in applying systems engineering standards and best practices to the Baxter Product Development process.
What you'll bring
  • Demonstrated success in leading the development of end-to-end systems, ideally in the medical device or healthcare industry.
  • Experience with V-Model and Agile product development methodologies.
  • Proven expertise in systems modeling, requirements management, risk analysis, verification, and validation.
  • Strong understanding of medical device regulations, quality systems, and data privacy regulations including ISO 13485, ISO 14971, IEC 60601, IEC 62304, 21 CFR Part 820, and GDPR.
  • Broad technical knowledge encompassing hardware (such as embedded systems and sensors), software (such as algorithms, cloud and mobile applications), and data engineering.
  • Experience in requirements definition and flow down, management, validation, and verification practices.
  • Demonstrated ability to work across disciplines to build consensus and drive complex systems to completion.
  • Understanding of medical device risk management and regulations.
  • Experience converting complex technical, business and regulatory requirements or challenges into clear and actionable strategies.
  • An autonomous self-starter personality with a culture of collaboration.
  • Detail-oriented with strong organization and time management skills, including the ability to multi-task across a diverse scope of responsibilities, projects, and people.
  • Effective verbal and written communication skills and the ability to facilitate and work effectively in diverse, multi-functional teams.
  • Bachelor's degree in Systems Engineering, Biomedical Engineering, Computer Engineering, or a related field.
  • Master's degree in same fields preferred.
  • 5+ years of experience in systems engineering, with a significant focus on connected medical devices or other complex, end-to-end systems involving hardware and software integration.
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 our employees, and we strive to be more transparent with our pay practices. To that end, this position has a salary range of $104,000 to $143,000 and also includes an annual incentive bonus. The above range represents the expected salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.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:Equal 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.Reasonable 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 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 .

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