{"id":2352760,"url":"https://alion.io/job/baxter-sr-engineer-codes-and-standards","title":"Sr Engineer, Codes and Standards","company":{"id":5835,"name":"Baxter","domain":"baxter.com","url":"https://alion.io/company/baxter","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"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":["Bengaluru, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":12500,"max_usd":31000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":20},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-12T14:11:54Z","employer_posted_date":"2026-10-12","last_verified_at":"2026-10-13T08:08:19Z","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.\nJob Summary\nA Systems engineering professional with experience in product systems architecture and systems level design, product requirements management, Traceability, Design History File (DHF) structure & maintenance, Compliance management, plans, requirements & testing, Product Risk management, System level integration and Validation of medical devices. This position may own & perform relevant Systems activities for the Patient Support Systems and Global Surgical Solutions products.\nWhat you’ll be doing\nResponsible for the coordination and development of the product systems architecture and systems level design, including the decomposition of the system architecture and requirements into subsystem and interface specifications.\nPerforms the activities associated with the Systems engineering of one or more products in various stages of the product lifecycle from new product development to post market surveillance.\nGathers inputs for Requirements from various sources such as Standards, User needs, Regulatory, Quality, Human factors, Manufacturing, Service and so on. Performs impacts assessment on the requirements on an ongoing basis for any proposed design/material/process change or an observation in the field/service or manufacturing to determine the impact and need for any mitigation. Come up with the recommended mitigation with the rationale.\nUnderstands clinical and user need and can apply to product realization. Creates and maintains Design History File elements.\nLeverages knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a systems perspective.\nDrives adherence to FDA, ISO and IEC design control procedures, regulations and standards.\nCan perform as an independent reviewer in technical and design reviews.\nInteract with clinical and marketing to develop and refine user requirements.\nCommunicate design requirements and provide technical guidance to suppliers as needed.\nEnsure user needs are captured, quality requirements are met and technical risks are mitigated.\nManage integration of deliverables from sub-system design teams and external partners.\nIdentify and define high level requirements for a product or a feature that enhance the quality of therapy\nIdentify and define high level requirements for a product or a feature that enhance the quality of therapy\nPlan and execute system integration activities to minimize issues in systems validation.\nDevelop test plans, test protocols, and test reports for product integration testing.\nDocument traceability from requirements to verification activities, and from requirements to design entities.\nResolve systems-related technical issues by applying problem solving tools such as cause-and-effect diagrams, Pareto charts, etc.\nDevelop and maintain an effective and corroborative working relationship with internal and external development partners.\nDevelop System requirements; propose architectures and connectivity specifications of medical devices with each other and with external medical systems.\nEnsure appropriate traceability between requirements, interface specifications, design and verification deliverables.\nAs Compliance Engineer\nCoordination and management of standards compliance activities for assigned programs, working with cross-functional product development partners to identify requirements, developing and execute compliance plans, coordinate testing activities, reviewing compliance testing results and partner with certification agencies to certify products.\nPartner with design engineers (Hardware, Mechanical, Software) to develop product requirements to comply with standards and regulations for intended use markets, develop Compliance Plans, participate in design and development activities and partner to resolve product certification, compliance and safety issues.\nConsult with program teams on product certification strategy and compliance issues where needed\nFacilitate and coordinate input from multiple cross-functional partners including Regulatory team, program management, R&D teams, manufacturing sites and service locations to develop comprehensive product certification and compliance strategies, and ensure that Baxter Healthcare solutions comply with product certification requirements in the intended use markets\nKeep abreast of changes to product standards and regulations affecting medical products.\nEnsure that all compliance test equipment complies with the test requirements specified in compliance standards.\nSchedule compliance testing for Baxter Healthcare products at onsite test facility and at external test laboratories. Manage product test and certification projects with onsite and external test laboratories.\nPrepare standards test reports and other documentation in accordance with applicable regulations.\nSubmit documentation to regulatory authorities as required to obtain product certifications for different global regions (e.g. US, Canada, Europe, Korea, Japan, Australia/New Zealand, Latin America, Caribbean, MEA)\nSupport the development System requirements and drive the cascade of the requirements to hardware and software subsystem requirements.\nEnsure appropriate traceability between requirements, interface specifications, design and verification deliverables.\nIdentify compliance risks and reliability related requirements from applicable product standards (collateral and particular).\nCollaborate with cross-functional resources (e.g. hardware, clinical, human factors, etc.) involved in designing for Compliance and ensure designs provide adequate margins.\nSupport sustaining teams in EMC investigation and identification of root causes.\nWhat you’ll bring\nMust possess a strong knowledge of engineering disciplines and solid knowledge of related disciplines, Electromechanical, Systems, Fluid Mechanics, Materials Sciences\nA demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products.\nStrong team player, able to meet deadlines and handle changing priorities.\nExperience in resolving complex technical problems using strong analytical skills.\nExcellent written, oral and interpersonal skills\nMust be proficient at time management and multitasking.\nAs Compliance Engineer\nKnowledge of medical device requirements for Global (US, Canada, Europe, Korea, Japan, Australia/New Zealand, Latin America, Caribbean, MEA)\nKnowledge and Hands on experience on all EMI/EMC standards/tests and knowledge of EMC regulations and certification procedures applicable to Medical Devices globally including testing documentation, certification requirements and procedures (i.e. IEC/EN60601, CISPR 11, FCC, EU, IC etc.).\nHands-on experience on Safety standards (IEC 60601 series) including collateral and particular standards\nIn depth knowledge on wireless regulations and standards (ETSI series, FCC, IC, RED (Radio equipment directives) for medical products\nFamiliarity with regulatory requirements of FDA and EU MDR.\nAbility to perform diagnostics and correct EMC failures in conjunction with design engineers\nStrong electronics background is essential\nStrong experience in Requirements Management, Configuration Management, Defect Tracking and Traceability\nExperience with EMC design tools, automated EMC testing tools, electronic test equipment (scopes, logic analyzers)\nKnowledge of FDA's guidance on design controls and software validation, as well as ANSI/IEEE standards for EMC engineering\nDemonstrated experience interfacing with regulatory agencies, conformity assessment bodies (UL, Intertek, CSA, etc.) and standards development organizations (IEC, ISO, NEMA, NFPA, ETSI, etc.).\nEducation and/or Experience\nGraduate or Postgraduate in Biomedical, Mechanical, Electrical, Electronics or related Engineering. An advanced technical degree is desired.\n8-10 years of relevant technical experience in defining systems and requirements for medical products.\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.\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":9770,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Health & Medical Electronics"],"lifecycle":[{"event":"open","at":"2026-10-12T14:11:54Z"}],"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":38,"reasons":["conf:1","win:early"],"computed_at":"2026-10-13T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/baxter-sr-engineer-codes-and-standards","json_url":"https://alion.io/job/baxter-sr-engineer-codes-and-standards.json","meta":{"generated_at":"2026-10-13T10:29:00Z","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":16010,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-14T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"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-codes-and-standards"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"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-codes-and-standards"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"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-codes-and-standards"},{"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-codes-and-standards\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbaxter-sr-engineer-codes-and-standards"}]}