{"id":3985788,"url":"https://alion.io/job/baxter-sr-principal-software-design-quality-engineer-relocation-assistance-provided","title":"Sr Principal Software Design Quality Engineer - Relocation Assistance Provided","company":{"id":5835,"name":"Baxter","domain":"baxter.com","url":"https://alion.io/company/baxter","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":92,"open_postings":27,"ghost_share":0,"stale_share":0.481,"repost_share":0.074,"time_to_fill_p50_days":17,"computed_at":"2026-11-09T06:03:00Z"}},"role":"QA","role_family":"QA","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Raleigh, United States","United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":128000,"max":176000,"currency":"USD","period":"year","gross":null,"usd_annual":176000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":true,"relocation_package":false,"has_equity":true,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"IEC 62304","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-11-09T21:33:17Z","employer_posted_date":"2026-11-09","last_verified_at":"2026-11-09T21:33:17Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"This is where your work makes a difference.\nAt 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.\nOur 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.\nHere, you will find more than just a job-you will find purpose and pride.\nYour role at Baxter\nThe Senior Principal Engineer, Software Design Quality serves as a senior technical authority for software design quality and design assurance throughout the product lifecycle. This position provides independent Quality leadership to ensure software and software-intensive medical devices are developed, verified, validated, released, and maintained in accordance with applicable design controls, software lifecycle processes, risk management requirements, regulatory requirements, and the Quality Management System. The primary focus is embedded software used in electromechanical medical devices, with potential future support for PC-based, web-based, connected, or interoperable software.\nYour Team\nThe Senior Principal Engineer partners with Software Engineering, Systems Engineering, Product Security, Human Factors, Regulatory Affairs, Medical/Clinical, Manufacturing, Post-Market Quality, and other functions to establish appropriate quality strategies and ensure that software product risks are identified[GC1.1][SF1.2], understood, controlled, and supported by objective evidence.\nThe role operates with a high degree of independence and is expected to influence technical and quality strategy across programs and product platforms. As the senior Software Design Quality representative, the individual is expected to make and defend difficult quality, safety, compliance, and release decisions with limited day-to-day supervision. The work will frequently involve iterative software releases, defect corrections, sustaining changes, and significant updates to existing requirements, traceability, and risk-management documentation in addition to traditional new-product development. The Senior Principal Engineer applies advanced engineering judgment to complex or ambiguous issues, challenges assumptions constructively, identifies systemic risks, and drives technically sound solutions that support safe, effective, reliable, and compliant medical devices.\nWhat you will be doing:\nServe as the senior Design Quality technical authority for medical device software projects across the full product lifecycle.\nProvide Design Quality oversight primarily for embedded software used in electromechanical medical devices, with the ability to support PC-based, web-based, connected, and interoperable software as product needs evolve.\nProvide independent Quality leadership for software development, sustaining engineering, design changes, and release decisions.\nOperate independently and make risk-based quality decisions with limited day-to-day supervision from geographically dispersed teams.\nEstablish risk-based software Design Quality strategies aligned with intended use, product architecture, development methodology, and regulatory expectations.\nDemonstrate understanding of and ensure adherence to applicable FDA regulations, ISO and IEC standards, design controls, software lifecycle processes, and Quality System requirements within the area of responsibility and expertise.\nEffect positive change on internal processes to improve team efficiency while maintaining the highest quality standards\nProvide Quality oversight of software lifecycle plans and deliverables from concept and planning through development, release, maintenance, and retirement.\nLead Quality oversight of iterative software releases, sustaining changes, defect corrections, cybersecurity updates, and significant revisions to software requirements, traceability, and risk-management documentation.\nEvaluate software requirements for completeness, clarity, consistency, testability, allocation, and linkage to user needs and system requirements.\nEnsure end-to-end traceability among requirements, architecture, risk controls, implementation, verification, validation, anomalies, and release evidence.\nLead Quality oversight of software risk management, including hazard analysis, risk-control implementation, traceability, and verification.\nProvide independent Quality oversight of software verification and validation strategies, methods, acceptance criteria, coverage, and results.\nOversee the characterization, investigation, risk assessment, disposition, and closure of software anomalies and defects.\nEvaluate unresolved anomalies and failed, incomplete, or inconclusive testing for potential impact on safety, effectiveness, essential performance, compliance, and release readiness.\nLead or support software release-readiness assessments and escalate unresolved technical, quality, safety, or compliance concerns when evidence is insufficient.\nProvide Quality oversight of software configuration management and design changes, including impact assessment, risk evaluation, testing scope, traceability, and approval.\nProvide Design Quality expertise for complex complaints, nonconformances, CAPAs, trend investigations, field issues, and root-cause investigations.\nEvaluate software defects, unresolved anomalies, complaints, post-market signals, and released-product risks to determine whether correction, removal, field action, or escalation to the Field Action Review Board or other formal governance process is warranted.\nLead resolution of complex, ambiguous, or cross-functional software quality issues and ensure resulting corrective and preventive actions are technically justified, appropriately verified, and translated into systemic improvements using objective evidence, engineering judgment, and risk-based reasoning.\nSupport internal and external audits, regulatory inspections, submissions, inquiries, and responses involving software design controls and lifecycle evidence.\nCommunicate Quality positions and technical risks clearly to engineers, cross-functional partners, and senior leadership while maintaining independent judgment.\nExperience utilizing AI-assisted and advanced analytical tools, with appropriate human oversight, within Software Quality\nMentor Design Quality engineers and promote scalable best practices, lessons learned, and continuous improvement across products and platforms.\nWhat you will bring:\nCompletely proficient in 21 CFR 820.30 - Design Controls, ISO 13485, ISO 14971, IEC 62304, and Quality System and regulatory requirements applicable to medical-device software.\nDemonstrated ability to apply risk-based decision making throughout software development and maintenance activities.\nCompletely proficient in software requirements engineering, including development, analysis, allocation, and traceability of software requirements.\nCompletely proficient in software anomaly and defect management, including characterization, investigation, risk assessment, disposition, and closure.\nCompletely proficient in software configuration management, including configuration identification, change control, status accounting, and release management.\nCompletely proficient in product and process development concepts, including change control and risk management.\nProblem Solving - Apply structured root-cause analysis, engineering judgment, risk evaluation, objective evidence, and appropriate statistical techniques to address complex issues and investigations. Resourceful and independent. Applies organizational and technical knowledge to move teams through issues.\nProven leadership skills and demonstrated ability to independently make and defend difficult software quality, safety, compliance, and release decisions using objective evidence and risk-based reasoning.\nExtensive experience leading and influencing geographically distributed cross-functional teams, including technical and non-technical work, without direct authority.\nExtensive experience providing Design Quality oversight for embedded software in regulated electromechanical medical devices; experience with PC-based, web-based, connected, or interoperable medical-device software is desired.\nDemonstrated experience assessing software defects and post-market issues for potential product correction, removal, field action, or escalation to formal quality governance boards.\nExperience utilizing AI-assisted and advanced analytical tools, with appropriate human oversight, within Software Quality\nASQ Certified Quality Engineer or equivalent experience desired.\nBachelors or Master’s Degree in the field of Software Engineering, Computer Science, Computer Engineering, Electrical Engineering, or a related engineering/scientific discipline.\nAdvanced training or certification related to software quality, cybersecurity or medical-device software quality desired\nOverall, 8+ years of Quality Engineering experience, including substantial direct experience in regulated software Design Quality and a minimum of 5+ years supporting software-centric projects. Experience should include embedded medical-device software, iterative or sustaining releases, defect corrections, requirements and risk-documentation updates, and post-market or release decisions.\nBaxter 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.\nWe 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 $128,000 to $176,000 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.\nApplicants 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.\nUS Benefits at Baxter (except for Puerto Rico)\nThis 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 pare...","description_format":"text","description_chars":13486,"description_truncated":true,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Flexible schedule","Insurance coverage","Parental leave","Retirement plans"],"hiring_locations":[],"hiring_excludes":[{"name":"Puerto Rico","iso":"PR"}],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Patient Monitoring","Hospital Equipment & Furniture","Infusion & Drug Delivery Devices"],"lifecycle":[{"event":"open","at":"2026-11-09T21:33:17Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":17,"reasons":["conf:2","win:early","comp:brand"],"computed_at":"2026-11-09T23:37:50Z"},"pay":{"stated_usd_annual":176000,"is_top_pay":true},"html_url":"https://alion.io/job/baxter-sr-principal-software-design-quality-engineer-relocation-assistance-provided","json_url":"https://alion.io/job/baxter-sr-principal-software-design-quality-engineer-relocation-assistance-provided.json","meta":{"generated_at":"2026-11-09T23:37:50Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":13471,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-10T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":5835},"rest":"https://alion.io/mcp/rest/get_company?id=5835"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbaxter-sr-principal-software-design-quality-engineer-relocation-assistance-provided"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fbaxter-sr-principal-software-design-quality-engineer-relocation-assistance-provided"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fbaxter-sr-principal-software-design-quality-engineer-relocation-assistance-provided"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/baxter-sr-principal-software-design-quality-engineer-relocation-assistance-provided\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbaxter-sr-principal-software-design-quality-engineer-relocation-assistance-provided"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3985788}},{"tool":"search_jobs","arguments":{"company":"baxter.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3985788},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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