{"id":3985792,"url":"https://alion.io/job/baxter-sr-engineer-design-quality","title":"Sr Engineer, Design Quality","company":{"id":5835,"name":"Baxter","domain":"baxter.com","url":"https://alion.io/company/baxter","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":94,"open_postings":43,"ghost_share":0,"stale_share":0.395,"repost_share":0.093,"time_to_fill_p50_days":18,"computed_at":"2026-11-14T05:58:10Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Batesville, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":96000,"max":132000,"currency":"USD","period":"year","gross":null,"usd_annual":132000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":true,"relocation_package":false,"has_equity":true,"technologies":[{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"IEC 60601","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":"2026-11-15T02:20:01Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"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\nThis is where my hands make life-sustaining products\nAs a Senior Engineer, Design Quality, you will serve as the quality partner for New Product Development and Sustaining Engineering projects. You will provide quality oversight throughout the product lifecycle, ensuring design controls, regulatory requirements, and quality standards are met. Working closely with cross-functional teams, you will identify and mitigate quality risks while helping deliver safe, effective, and compliant medical devices.\nYour Team\nYou will join a collaborative Quality team that partners with R&D, Regulatory Affairs, Manufacturing, and Supplier Quality to bring innovative healthcare products to market. Together, you will drive quality excellence, support compliance, manage risk, and help improve outcomes for patients around the world.\nWhat we offer from Day One\nShift flexibility to trade shifts and leverage overtime opportunities\nMedical, Dental and Vision coverage\n160 hours of Paid Time Off and Paid Holidays\n401K match\nEmployee Stock Purchase Program\nPaid Parental Leave\nTuition Reimbursement\nWhat you’ll be doing\nResponsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities.\nIdentify and assess regulatory and quality risk in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.\nProvide quality assurance support and oversight for product design activities including: Design and Development Planning, Design Input, Design Output, Design Review, Design Verification and Validation, Design Transfer, Design Changes.\nEnsure compilation and maintenance of product Design History Files in collaboration with R&D.\nPartner with Sustaining Engineering and Research & Development to ensure design reviews are thorough and robust.\nWhat you’ll bring\nBachelor’s degree in engineering\n3-5 years experience in Quality with a medical device / Pharma company or other similarly regulated industry.\nStrong problem-solving and root cause analysis skills.\nExperience with structured methods such as 5 Why, fault tree analysis, design or process Failure Modes and Effects Analysis, DMAIC, or equivalent approaches is preferred.\nDemonstrated working knowledge of medical device design controls and product lifecycle management for New Product Development and sustaining activities.\nWorking knowledge of applicable quality system and risk management requirements, including ISO 13485, ISO 14971, Regulation (EU) 2017/745, and U.S. FDA Quality System requirements. Knowledge of applicable IECand ISO product standards (ex: IEC 62304, IEC 60601-1, ISO 62366-1, etc…) is expected for the assigned product scope\nAbility to review technical documentation and determine whether requirements, methods, results, conclusions, and traceability are scientifically and objectively supported\nAbility to apply or critically review statistical methods used for verification, validation, reliability, sampling, and process or product data analysis.\nStrong written and verbal communication skills. Able to explain complex quality or technical topics clearly to technical teams and management.\nSelf-motivated, organized, detail oriented, and able to manage multiple priorities while maintaining accurate and complete records.\nAbility to challenge constructively, make decisions, and escalate concerns when evidence is insufficient or patient safety, product quality, or compliance may be affected. · Experience supporting audits or regulatory inspections is preferred.\nProfessional certification in quality engineering, reliability, software quality, Lean, or Six Sigma is preferred.\nExperience with working in an environment subject to compliance with 21 CFR Parts 820, and FDA Inspection experience preferred.\nApplicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.\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 $96,000 - $132,000 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 upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, commission, and/or long-term incentive.\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 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\nEqual Employment Opportunity\nBaxter 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.\nKnow Your Rights: Workplace Discrimination is Illegal\nReasonable Accommodations\nBaxter 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.\nRecruitment Fraud Notice\nBaxter 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.","description_format":"text","description_chars":7813,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","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":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":4,"expected_fill_days":18,"reasons":["conf:2","velocity","win:early","comp:brand"],"computed_at":"2026-11-14T05:58:10Z"},"pay":{"stated_usd_annual":132000,"is_top_pay":false},"html_url":"https://alion.io/job/baxter-sr-engineer-design-quality","json_url":"https://alion.io/job/baxter-sr-engineer-design-quality.json","meta":{"generated_at":"2026-11-15T04:58:15Z","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":47,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-16T00:00:00Z"}},"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-engineer-design-quality"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"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-engineer-design-quality"},{"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-engineer-design-quality"},{"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-engineer-design-quality\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbaxter-sr-engineer-design-quality"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3985792}},{"tool":"search_jobs","arguments":{"company":"baxter.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3985792},"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. Docs: https://alion.io/developers"}}